Device manufacturer, as written on reports

C R Bard Basd -3006260740: medical device reports filed with FDA

44,113 reports name it as the manufacturer of the device involved, 2015–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

44,113
reports naming it as manufacturer: 0.2% of all MAUDE reports; 10,411
reports, 12 months to August 2026: 10,021 in the 12 months before; 76.2%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

44,113 medical device reports received by FDA give C R Bard Basd -3006260740 as the manufacturer of the device involved, 0.2% of the MAUDE database, from October 2015 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

10,411 reports arrived in the 12 months to August 2026, close to the 10,021 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (76.2%), injury (23.1%) and death (0.8%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F	Port & catheter, implanted, subcutaneous, intravascular	1,318	656	4.7%
Navarre Opti Drain	Catheter, irrigation	1,301	455	0%
Navarre Universal Drain	Catheter, irrigation	1,238	335	0%
PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F	Port & catheter, implanted, subcutaneous, intravascular	1,014	211	1.3%
PowerPICC	Catheter, intravascular, therapeutic, long-term greater than 30 days	766	577	0.1%
GlidePath	Catheter, hemodialysis, implanted	750	225	0.9%
PowerPICC SOLO2	Catheter, intravascular, therapeutic, long-term greater than 30 days	678	488	0%
PowerPICC SOLO2, 3CG	Catheter, intravascular, therapeutic, long-term greater than 30 days	651	137	0%
Bard PICC	Catheter, intravascular, therapeutic, long-term greater than 30 days	630	84	0%
PowerPort M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F	Port & catheter, implanted, subcutaneous, intravascular	618	341	4.2%
PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F	Port & catheter, implanted, subcutaneous, intravascular	598	350	4.6%
Site Rite 8 Ultrasound System 20mm Cue Linear Probe	System, imaging, pulsed echo, ultrasonic	446	0	0%
Groshong CLEARVUE	Catheter, intravascular, therapeutic, long-term greater than 30 days	419	415	0%
Groshong NXT ClearVue	Catheter, intravascular, therapeutic, long-term greater than 30 days	393	150	0%
Implanted Port	Port & catheter, implanted, subcutaneous, intravascular	389	368	4.3%
Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer	Catheter, intravascular, therapeutic, long-term greater than 30 days	381	0	0.1%
PowerLoc	Set, administration, intravascular	364	231	0%
SafeStep	Set, administration, intravascular	364	168	0%
Powerloc Max Power-Injectible Infusion Set 20g X 0 75in	Set, administration, intravascular	353	0	0%
PowerPort isp MRI 6F CHRONW/OS	Port & catheter, implanted, subcutaneous, intravascular	353	183	0%
HemoStar	Catheter, hemodialysis, implanted	348	84	0.8%
Powerpicc 3cg	Catheter, intravascular, therapeutic, long-term greater than 30 days	340	18	0%
Unknown Port	Port & catheter, implanted, subcutaneous, intravascular	295	16	0.7%
Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray	Catheter, intravascular, therapeutic, long-term greater than 30 days	282	0	0.3%
Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray	Catheter, intravascular, therapeutic, long-term greater than 30 days	261	0	0%
Universal Microintroducer Kit Ptfe Peel-Apart Sheath Introducer 4 5f X 5cm	Introducer, catheter	256	0	0%
Site-Rite 8 Ultrasound	System, imaging, pulsed echo, ultrasonic	252	0	0%
Groshong Nxt Clearvue 4f Single-Lumen Basic Tray	Catheter, intravascular, therapeutic, long-term greater than 30 days	241	0	0%
Site Rite 8 Ultrasound System Console With Connector	System, imaging, pulsed echo, ultrasonic	235	0	0%
PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F	Port & catheter, implanted, subcutaneous, intravascular	228	164	5.4%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	16,828	38.1%
LJT	Port & catheter, implanted, subcutaneous, intravascular	11,674	26.5%
FPA	Set, administration, intravascular	3,452	7.8%
GBX	Catheter, irrigation	2,571	5.8%
IYO	System, imaging, pulsed echo, ultrasonic	2,510	5.7%
MSD	Catheter, hemodialysis, implanted	2,044	4.6%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	1,292	2.9%
DYB	Introducer, catheter	831	1.9%
PND	Midline catheter	478	1.1%
ITX	Transducer, ultrasonic, diagnostic	290	0.7%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.8%344

Injury23.1%10,170

Malfunction76.2%33,599

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about C R Bard Basd -3006260740 reports

How many FDA device reports name C R Bard Basd -3006260740 as manufacturer?

44,113 reports through August 2026, 10,411 of them in the latest 12 months.

Which of its brands appear most often?

PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F (1,318), Navarre Opti Drain (1,301), Navarre Universal Drain (1,238), PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F (1,014) and PowerPICC (766).

Which device types does it report on?

catheter, intravascular, therapeutic, long-term greater than 30 days (38.1%), port & catheter, implanted, subcutaneous, intravascular (26.5%), set, administration, intravascular (7.8%) and catheter, irrigation (5.8%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.