Reported Reactions

Devices › Set, administration, intravascular

Device brand name · Set administration intravascular

Cadd Medication Cassette Reservoirs With Flow Stop: medical device reports filed with FDA

764 reports name it, 2018–2023. Manufacturer given most often on reports: St Paul. Product code FPA.

764
device reports naming the brand
0% of all MAUDE reports · about 94 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.9%
classified as malfunction
79.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

764 medical device reports received by FDA name the brand "Cadd Medication Cassette Reservoirs With Flow Stop" (set administration intravascular); the manufacturer given most often on reports is St Paul; received from May 2018 to July 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (99.9%) and injury (0.1%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device alarm system (54.3%), leak/splash (12.2%) and fluid/blood leak (6.5%). The patient problems coded most often are anxiety, no patient involvement and inadequate pain relief. 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."

Reports by month, five years

084168Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 2Feb 2022: 7Mar 2022: 125Apr 2022: 33May 2022: 168Jun 2022: 49Jul 2022: 33Aug 2022: 112Sep 2022: 40Oct 2022: 42Nov 2022: 23Dec 2022: 242023Jan 2023: 62Feb 2023: 4Mar 2023: 0Apr 2023: 0May 2023: 3Jun 2023: 0Jul 2023: 1Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

By year received

03296582018: 2220182019: 720192021: 720212022: 65820222023: 702023

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.1%1
Malfunction99.9%763
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%764
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 349,387 reports carrying product code FPA. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device alarm system41554.3%1.5%
Leak/splashthe device leaked9312.2%11.2%
Fluid/blood leak506.5%13.5%
Connection problema connection problem283.7%0.5%
Inaccurate delivery283.7%0.2%
Audible prompt/feedback problem182.4%0.1%
Insufficient flow or under infusion121.6%0.6%
Infusion or flow problema problem with flow or infusion111.4%3%
Contamination /decontamination problem101.3%0.2%
Failure to prime91.2%0.5%
Mechanical problema mechanical problem91.2%0.1%
Breakthe device broke81%2.1%
Defective component60.8%0.5%
Air/gas in device50.7%0.9%
Filling problem50.7%0.2%
Improper flow or infusion50.7%0.4%
Detachment of device or device componentpart of the device came off40.5%3.9%
Device damaged prior to usethe device was damaged before use40.5%0.1%
Insufficient device problem information40.5%0.3%
No flow40.5%1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Anxietyanxiety50.7%
No patient involvement50.7%
Inadequate pain relief20.3%
Endocarditis10.1%
Low blood pressure/ hypotension10.1%
Painpain, site not specified10.1%
Syncope/fainting10.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureCadd Medication Cassette Reservoirs With Flow StopProduct code FPAAll MAUDE reports
Reports764349,38726,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports029
Classified as injury0.1%20%36.2%
Classified as malfunction99.9%79.3%62.3%
Filed by the manufacturer100%96.3%94.9%

Shares are of reports, not 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."

Other brands with product code FPA

BrandReportsLatest 12 monthsClassified as death
Inset Guard47,27647,2220.1%
Inset26,40525,6560%
Quick Set23,35123,0280.4%
Autosoft Xc20,328490%
Autosoft 9012,143150%
Access14,16000%
Other Accessories10,42910,4251.7%
Alaris Pump Module Administration Set8,49200.2%
Contact Detach6,4736,1570.1%
Inset 303,5283,4610%
Cadd10,81190.1%
Minimed Quick-Set3,10160%
Cleo 90 Infusion Set3,006230%
Trusteel2,886140%
Autosoft 302,37410%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Cadd Medication Cassette Reservoirs With Flow Stop reports

How many FDA reports name Cadd Medication Cassette Reservoirs With Flow Stop?

764 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (99.9%) and injury (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (54.3%), leak/splash (12.2%), fluid/blood leak (6.5%), connection problem (3.7%) and inaccurate delivery (3.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Cadd Medication Cassette Reservoirs With Flow Stop was at fault?

No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.