Collector, urine, (and accessories) for indwelling catheter: medical device reports filed with FDA

2,156 reports carry this product code, 1992–2026; 12 brands with a page.

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.

2,156
reports with this product code: 0% of all MAUDE reports; 238
reports, 12 months to August 2026: 197 in the 12 months before; 89.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code KNX is FDA's classification for "Collector, urine, (and accessories) for indwelling catheter" (gastroenterology, Urology panel), a class 2 device. 2,156 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to August 2026.

238 reports arrived in the 12 months to August 2026, up 21% from 197 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 (89.7%), injury (9.7%) and other (0.3%). 12 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Bard Urine Meter with Bag	322	73	0%	96%
Bard Urinary Drainage Bag	241	33	0%	90.9%
Urine Collection	232	0	0%	94.1%
Bard Urinary Drainage Bag with Anti-Reflux Chamber	189	20	0%	88.9%
EnCor Biopsy Probe	6	15	0%	99%
Dover	4	32	0.6%	87.7%
Rusch	3	0	1.8%	89.8%
Kendall	2	23	2.3%	61.5%
All-In-One Container	1	0	0%	100%
Bardex Lubri-Sil I.C. All-Silicone Foley Catheter	1	620	0%	97.6%
Latex Foley Catheter	1	7	0%	81.3%
Surestep	1	0	0.1%	95.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
C R Bard Covington -1018233	1,593	73.9%
Productos Para El Cuidado De La Salud -9611590	137	6.4%
C R Bard	41	1.9%
Cardinal Health	35	1.6%
Baxter Healthcare - Cali	13	0.6%
Bard	9	0.4%
Medline Industries	4	0.2%
Unomedical S R O	4	0.2%
Medivance 1725056	2	0.1%
Bard Shannon	1	0%
Baxter Healthcare - Malta	1	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 and report source

Event type

Death0%0

Injury9.7%209

Malfunction89.7%1,935

Other0.3%7

Not given0.2%5

Who filed

Manufacturer report94.5%2,037

Voluntary report2%43

User facility report0%0

Distributor report0.7%15

Not given2.8%61

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Restricted flow rate	631	29.3%
Deformation due to compressive stress	238	11%
Fluid/blood leak	178	8.3%
No flow	157	7.3%
Leak/splashthe device leaked	91	4.2%
Component missing	86	4%
Component misassembled	81	3.8%
Material twisted/bent	79	3.7%
Obstruction of flow	61	2.8%
Device operates differently than expectedthe device behaved unexpectedly	60	2.8%
Device contamination with chemical or other material	54	2.5%
Partial blockage	53	2.5%
Disconnection	44	2%
Kinkedthe tube or line kinked	43	2%
Physical resistance/sticking	40	1.9%
Deflation problem	31	1.4%
Improper flow or infusion	31	1.4%
Infusion or flow problema problem with flow or infusion	28	1.3%
Material deformation	26	1.2%
Material fragmentation	23	1.1%

Questions about collector, urine, (and accessories) for indwelling catheter reports

What is product code KNX?

FDA's classification code for "Collector, urine, (and accessories) for indwelling catheter", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,156 reports through August 2026, 238 of them in the latest 12 months.

Which brands appear most often?

Bard Urine Meter with Bag (322), Bard Urinary Drainage Bag (241), Urine Collection (232), Bard Urinary Drainage Bag with Anti-Reflux Chamber (189) and EnCor Biopsy Probe (6). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.