Device brand name · Tube drainage suprapubic

Flexima Catheter: medical device reports filed with FDA

157 reports name it, 1996–2018. Manufacturer given most often on reports: Boston Scientific - Spencer. Product code FFA.

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.

157
device reports naming the brand: 0% of all MAUDE reports · about 5 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 54.1%
classified as malfunction: 61.4% across the product code; 1.9%
classified as death, as reported: 3 reports · not verified by FDA

157 medical device reports received by FDA name the brand "Flexima Catheter" (tube drainage suprapubic); the manufacturer given most often on reports is Boston Scientific - Spencer; received from September 1996 to July 2018. 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 (54.1%), injury (43.9%) and death (1.9%); across all tube, drainage, suprapubic reports (product code FFA) death is recorded in 0.7% and malfunction in 61.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fracture (17.8%), replace (17.8%) and break (13.4%). The patient problems coded most often are therapy/non-surgical treatment, additional, foreign body, removal of and no patient involvement. 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

No report naming Flexima Catheter was received in the five years to August 2026; the latest was received in July 2018.

By year received

Event type and report source

Event type, as classified on the report

Death1.9%3

Injury43.9%69

Malfunction54.1%85

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%157

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 677 reports carrying product code FFA. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Fracturea broken bone	28	17.8%	5.2%
Replace	28	17.8%	0%
Breakthe device broke	21	13.4%	27.6%
Difficult to removethe device was hard to remove	17	10.8%	11.4%
Explanted	17	10.8%	0%
Source, detachment from	16	10.2%	0%
Detachment of device component	15	9.6%	4.4%
Shaft break	14	8.9%	0%
Device, or device fragments remain in patient	11	7%	0.9%
Device contamination with chemical or other material	6	3.8%	3.1%
Migration or expulsion of device	5	3.2%	1.5%
Shaft, split	5	3.2%	0%
Device, removal of (non-implant)	4	2.5%	0.1%
Unsealed device packaging	4	2.5%	1.6%
Implant, removal of	3	1.9%	0%
Kinkedthe tube or line kinked	3	1.9%	1.3%
Tear, rip or hole in device packaging	3	1.9%	3.5%
Tip breakage	3	1.9%	0%
Bent	2	1.3%	0.6%
Crackthe device cracked	2	1.3%	0.1%

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)	Reports	Share
Therapy/non-surgical treatment, additional	24	15.3%
Foreign body, removal of	17	10.8%
No patient involvement	16	10.2%
Surgical procedure	16	10.2%
Nonresorbable materials, unretrieved in body	11	7%
Surgical procedure, additional	7	4.5%
Device embedded in tissue or plaque	6	3.8%
Surgical procedure, repeated	5	3.2%
Discomfortdiscomfort	2	1.3%
Failure of implant	2	1.3%
Abscessa collection of pus	1	0.6%
Ascitesfluid in the abdomen	1	0.6%
Calcium deposits/calcification	1	0.6%
Foreign body in patientpart of a device left in the patient	1	0.6%
Hospitalization required	1	0.6%

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

In context

Measure	Flexima Catheter	Product code FFA	All MAUDE reports
Reports	157	677	26,136,888
Share of that pool	—	23.2%	0%
Classified as death, per 1,000 reports	19	7	9
Classified as injury	43.9%	36.6%	36.2%
Classified as malfunction	54.1%	61.4%	62.3%
Filed by the manufacturer	100%	88.6%	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 FFA

Brand	Reports	Latest 12 months	Classified as death
Flexima APDL	268	21	1.1%
Flexima?	257	10	0.4%
BLAKE Drain	738	4	1.8%
Zimmer	1,159	0	2.8%

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 Flexima Catheter reports

How many FDA reports name Flexima Catheter?

157 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 (54.1%), injury (43.9%) and death (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (17.8%), replace (17.8%), break (13.4%), difficult to remove (10.8%) and explanted (10.8%). 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 Flexima Catheter 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.