Device manufacturer, as written on reports

Bard Access Systems: medical device reports filed with FDA

21,057 reports name it as the manufacturer of the device involved, 1992–2026.

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.

21,057
reports naming it as manufacturer: 0.1% of all MAUDE reports; 118
reports, 12 months to August 2026: 207 in the 12 months before; 78.3%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

21,057 medical device reports received by FDA give Bard Access Systems as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

118 reports arrived in the 12 months to August 2026, down 43% from 207 in 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 (78.3%), injury (19.8%) 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
Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer	Catheter, intravascular, therapeutic, long-term greater than 30 days	387	0	0.1%
Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray With Microintroducer	Catheter, intravascular, therapeutic, long-term greater than 30 days	312	0	0.5%
Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f	Catheter, intravascular, therapeutic, long-term greater than 30 days	252	0	0%
Site-Rite 8 Ultrasound	System, imaging, pulsed echo, ultrasonic	247	0	0%
Bard	Port & catheter, implanted, subcutaneous, intravascular	188	2	1.8%
Universal Microintroducer Kit Ptfe Peel-Apart Sheath Introducer 4 5f X 5cm	Introducer, catheter	176	0	0%
Per-Q-Cath Plus 2f Single-Lumen Picc With Stiffening Stylet Basic Tray 30 Cm	Catheter, intravascular, therapeutic, long-term greater than 30 days	169	0	0%
Safestep Huber Needle Set 20g X 0 75in With Y-Site	Set, administration, intravascular	139	0	0%
Safestep Huber Needle Set 20g X 0 75in	Set, administration, intravascular	116	0	0%
PowerPICC Provena	Catheter, intravascular, therapeutic, long-term greater than 30 days	107	102	0%
Safestep Huber Needle Set 22g X 0 75in	Set, administration, intravascular	87	0	0%
Bard PICC	Catheter, intravascular, therapeutic, long-term greater than 30 days	79	84	0%
Powerloc Max Power-Injectible Infusion Set 20g X 0 75in	Set, administration, intravascular	76	0	0%
Port Access Needle	Set, administration, intravascular	73	16	0%
Site Rite 8 Ultrasound System Console With Connector	System, imaging, pulsed echo, ultrasonic	73	0	0%
Unknown Port	Port & catheter, implanted, subcutaneous, intravascular	73	16	0.7%
Site-Rite 8 Ultrasound Systsem Console Remanufactured	System, imaging, pulsed echo, ultrasonic	67	0	0%
Groshong Catheter	Catheter, intravascular, diagnostic	62	58	1.9%
Groshong 4f Single-Lumen Picc 60cm	Catheter, intravascular, therapeutic, long-term greater than 30 days	53	0	0%
PowerPICC	Catheter, intravascular, therapeutic, long-term greater than 30 days	50	577	0.1%
Statlock Picc Plus Crescent Sliding Post	Stand, infusion	29	0	0%
PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F	Port & catheter, implanted, subcutaneous, intravascular	28	211	1.3%
Powerloc Safety Infusion Set 20g X 0 75in	Set, administration, intravascular	22	0	0%
HemoSplit Catheter	Catheter, hemodialysis, implanted	15	49	1.6%
Catheter	Pump, infusion, implanted, programmable	14	9	3.7%
Implanted Port	Port & catheter, implanted, subcutaneous, intravascular	10	368	4.3%
PowerLoc	Set, administration, intravascular	10	231	0%
Port-A-Cath	Port & catheter, implanted, subcutaneous, intravascular	6	0	0%
Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray	Catheter, intravascular, therapeutic, long-term greater than 30 days	3	0	0.3%
PowerPort Slim Implantable Port, ChronoFlex Single-Lumen, 6F	Port & catheter, implanted, subcutaneous, intravascular	2	77	4.7%

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	8,322	39.5%
LJT	Port & catheter, implanted, subcutaneous, intravascular	3,120	14.8%
DQO	Catheter, intravascular, diagnostic	1,776	8.4%
FPA	Set, administration, intravascular	1,764	8.4%
MSD	Catheter, hemodialysis, implanted	1,169	5.6%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	1,060	5%
IYO	System, imaging, pulsed echo, ultrasonic	748	3.6%
KNT	Tubes, gastrointestinal (and accessories)	503	2.4%
LFJ	Catheter, subclavian	344	1.6%
DYB	Introducer, catheter	303	1.4%

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%160

Injury19.8%4,178

Malfunction78.3%16,489

Other0.4%78

Not given0.7%152

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

Questions about Bard Access Systems reports

How many FDA device reports name Bard Access Systems as manufacturer?

21,057 reports through August 2026, 118 of them in the latest 12 months.

Which of its brands appear most often?

Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer (387), Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray With Microintroducer (312), Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f (252), Site-Rite 8 Ultrasound (247) and Bard (188).

Which device types does it report on?

catheter, intravascular, therapeutic, long-term greater than 30 days (39.5%), port & catheter, implanted, subcutaneous, intravascular (14.8%), catheter, intravascular, diagnostic (8.4%) and set, administration, intravascular (8.4%).

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.