Device manufacturer, as written on reports

Becton Dickinson Infusion Therapy Systems: medical device reports filed with FDA

14,016 reports name it as the manufacturer of the device involved, 1997–2026.

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.

14,016
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,642
reports, 12 months to August 2026: 2,042 in the 12 months before; 82.8%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

14,016 medical device reports received by FDA give Becton Dickinson Infusion Therapy Systems as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 1997 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,642 reports arrived in the 12 months to August 2026, down 20% from 2,042 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 (82.8%), other (9.2%) and injury (7.6%). 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
Insyte AUTOGUARD	Catheter, intravascular, therapeutic, short-term less than 30 days	1,004	1,050	0%
BD Insyte Autoguard	Catheter, intravascular, therapeutic, short-term less than 30 days	746	55	0%
Bd Insyte Autog Bc	Catheter, intravascular, therapeutic, short-term less than 30 days	682	0	0%
Nexiva	Catheter, intravascular, therapeutic, short-term less than 30 days	263	304	0%
BD Nexiva	Catheter, intravascular, therapeutic, short-term less than 30 days	225	14	0%
First Picc Peripherally Inserted Central Catheter	Catheter, intravascular, therapeutic, long-term greater than 30 days	221	0	1.8%
Bd Nexiva Single Port	Catheter, intravascular, therapeutic, short-term less than 30 days	218	0	0%
BD Vacutainer Push Button Blood Collection Set	Tubes, vials, systems, serum separators, blood collection	199	324	0%
Q-Syte	Set, administration, intravascular	166	209	0%
Bd Q-Syte Closed Luer Access Device	Set, administration, intravascular	158	1	0%
Bd Insyte Autog Bc Wing	Catheter, intravascular, therapeutic, short-term less than 30 days	157	15	0%
Bd Q-Syte Luer Access Split Septum	Set, administration, intravascular	63	0	1%
First Picc	Catheter, intravascular, therapeutic, short-term less than 30 days	25	0	0.4%
Bd Q-Syte Luer Access Split-Septum Stand-Alone Device	Set, administration, intravascular	8	0	0.2%
Bd	Syringe, piston	4	0	1%
BD Vacutainer SST Blood Collection Tubes	Tubes, vials, systems, serum separators, blood collection	3	702	0%
Bd Connecta Stopcock	Stopcock, i.v. set	2	0	0%
Bd Insyte	Catheter, intravascular, therapeutic, short-term less than 30 days	1	0	0%
Interlink Injection Site	Catheter, intravascular, therapeutic, short-term less than 30 days	1	0	0%

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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	12,296	87.7%
FPA	Set, administration, intravascular	725	5.2%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	392	2.8%
JKA	Tubes, vials, systems, serum separators, blood collection	335	2.4%
DQO	Catheter, intravascular, diagnostic	106	0.8%
FMF	Syringe, piston	35	0.2%
DYB	Introducer, catheter	32	0.2%
FMI	Needle, hypodermic, single lumen	26	0.2%
DQY	Catheter, percutaneous	10	0.1%
FMG	Stopcock, i.v. set	7	0%

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

Death0.1%14

Injury7.6%1,059

Malfunction82.8%11,608

Other9.2%1,289

Not given0.3%46

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

Questions about Becton Dickinson Infusion Therapy Systems reports

How many FDA device reports name Becton Dickinson Infusion Therapy Systems as manufacturer?

14,016 reports through August 2026, 1,642 of them in the latest 12 months.

Which of its brands appear most often?

Insyte AUTOGUARD (1,004), BD Insyte Autoguard (746), Bd Insyte Autog Bc (682), Nexiva (263) and BD Nexiva (225).

Which device types does it report on?

catheter, intravascular, therapeutic, short-term less than 30 days (87.7%), set, administration, intravascular (5.2%), catheter, intravascular, therapeutic, long-term greater than 30 days (2.8%) and tubes, vials, systems, serum separators, blood collection (2.4%).

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.