Device manufacturer, as written on reports

Baxter Healthcare - Malta: medical device reports filed with FDA

4,281 reports name it as the manufacturer of the device involved, 2010–2019.

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.

4,281
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

4,281 medical device reports received by FDA give Baxter Healthcare - Malta as the manufacturer of the device involved, 0% of the MAUDE database, from February 2010 to November 2019. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (99.5%) and injury (0.4%). 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
Access	Set, administration, intravascular	2,109	0	0%
Ivt Disposable	Container, i.v.	1,299	0	0%
All-In-One Container	Container, i.v.	68	0	0%
Clearlink Luer Activated Valve	Set, administration, intravascular	54	6	0%
Solution Administration Sets	Set, administration, intravascular	49	23	0%
Solution Sets	Set, administration, intravascular	46	7	0%
Solution Set	Set, administration, intravascular	26	29	0%
Clearlink Continu-Flo Solution Set	Set, administration, intravascular	25	6	0.1%
Stopcock	Stopcock, i.v. set	20	16	0%
Blood Recipient Set	Set, blood transfusion	15	31	0%
I.V. Administration Sets with Control-A-Flo Regulator	Set, administration, intravascular	14	13	0%
Vial-Mate Reconstitution Device	Set, i.v. fluid transfer	14	0	0%
Buretrol Solution Sets	Set, administration, intravascular	11	8	0%
Clearlink Solution Administration Sets	Set, administration, intravascular	11	18	0%
Interlink	Set, administration, intravascular	6	49	0%
Clearlink Solution Set	Set, administration, intravascular	4	3	0%
Flogard	Pump, infusion	3	0	0%
Ni	Set, administration, for peritoneal dialysis, disposable	2	1,587	1.8%
Clearlink Duo-Vent Solution Administration Sets	Set, administration, intravascular	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
FPA	Set, administration, intravascular	2,293	53.6%
KPE	Container, i.v.	822	19.2%
LHI	Set, i.v. fluid transfer	660	15.4%
BRZ	Set, blood transfusion	322	7.5%
FMG	Stopcock, i.v. set	94	2.2%
LJH	System, irrigation, urological	66	1.5%
FRN	Pump, infusion	9	0.2%
KDJ	Set, administration, for peritoneal dialysis, disposable	5	0.1%
FKX	System, peritoneal, automatic delivery	2	0%
NEP	System/device, pharmacy compounding	2	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%0

Injury0.4%18

Malfunction99.5%4,258

Other0%0

Not given0.1%5

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

Questions about Baxter Healthcare - Malta reports

How many FDA device reports name Baxter Healthcare - Malta as manufacturer?

4,281 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Access (2,109), Ivt Disposable (1,299), All-In-One Container (68), Clearlink Luer Activated Valve (54) and Solution Administration Sets (49).

Which device types does it report on?

set, administration, intravascular (53.6%), container, i.v. (19.2%), set, i.v. fluid transfer (15.4%) and set, blood transfusion (7.5%).

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.