Device manufacturer, as written on reports

Hospira Costa Rica: medical device reports filed with FDA

16,397 reports name it as the manufacturer of the device involved, 2009–2018.

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.

16,397
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 97.8%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

16,397 medical device reports received by FDA give Hospira Costa Rica as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2009 to December 2018. 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 (97.8%), injury (1.6%) and death (0.3%). 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
Symbiq Dual Channel	Pump, infusion	933	0	0.1%
Symbiq Single Channe	Pump, infusion	833	0	0.1%
Plum A+ Driver Ed 2	Pump, infusion	687	0	0.4%
Plma Dvc V11 51 1 N	Pump, infusion	650	0	0%
Gemstr 7 Thpy Alt St	Pump, infusion	540	0	0%
Plum Xlm W/Dataport	Pump, infusion	513	0	0.2%
Symbiq Dchannel 3 01	Pump, infusion	483	0	0%
Plumset Clave Port Clave Site 103in Ndhp	Pump, infusion	480	0	0%
Symbiq Schannel 3 01	Pump, infusion	463	0	0%
Gemstar Pain Mge Sng	Pump, infusion	453	0	0%
Symbiq 3 13 Dual Cha	Pump, infusion	325	0	2%
Symbiq Single Channel	Pump, infusion	320	0	0%
Plm A+ Spanish Devic	Pump, infusion	319	0	0.3%
Plum A+ Driver New 8	Pump, infusion	305	0	0.5%
Plum A+ Driver New	Pump, infusion	286	0	0%
Plma Dvc V11 51 1 R	Pump, infusion	279	0	0.3%
Plm A+ Spanish 110v	Pump, infusion	265	0	0.4%
Plum Xld 110v L A	Pump, infusion	249	0	0.4%
Xld 110v L A Ref	Pump, infusion	235	0	0%
Symbiq 3 13 Single C	Pump, infusion	225	0	0.4%
Plum 360 Driver New	Pump, infusion	171	20	1.6%
Lifecare Pca 3 V5 06	Pump, infusion, pca	164	0	1.9%
Plum A + Driver New	Pump, infusion	162	0	0.6%
Acclaim Encore 2 25	Pump, infusion	146	0	0%
Lc Pca Hospira Medne	Pump, infusion, pca	134	0	0%
Dc Plum W/Sec Convpn 48/Case	Pump, infusion	127	0	0%
Plum Xlm W/Modifd B	Pump, infusion	77	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
FRN	Pump, infusion	14,584	88.9%
FPA	Set, administration, intravascular	975	5.9%
MEA	Pump, infusion, pca	718	4.4%
FPK	Tubing, fluid delivery	66	0.4%
KDC	Instrument, surgical, disposable	21	0.1%
DRS	Transducer, blood-pressure, extravascular	10	0.1%
FPB	Filter, infusion line	6	0%
BRZ	Set, blood transfusion	4	0%
CAK	Microfilter, blood transfusion	4	0%
KPE	Container, i.v.	4	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

Death0.3%51

Injury1.6%264

Malfunction97.8%16,033

Other0%3

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 Hospira Costa Rica reports

How many FDA device reports name Hospira Costa Rica as manufacturer?

16,397 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Symbiq Dual Channel (933), Symbiq Single Channe (833), Plum A+ Driver Ed 2 (687), Plma Dvc V11 51 1 N (650) and Gemstr 7 Thpy Alt St (540).

Which device types does it report on?

pump, infusion (88.9%), set, administration, intravascular (5.9%), pump, infusion, pca (4.4%) and tubing, fluid delivery (0.4%).

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.