Catheter, irrigation: medical device reports filed with FDA

5,889 reports carry this product code, 1993–2026; 14 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.

5,889
reports with this product code: 0% of all MAUDE reports; 1,141
reports, 12 months to August 2026: 1,179 in the 12 months before; 81.6%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code GBX is FDA's classification for "Catheter, irrigation" (general, Plastic Surgery panel), a class 1 device. 5,889 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to August 2026.

1,141 reports arrived in the 12 months to August 2026, close to the 1,179 of 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 (81.6%), injury (17.7%) and death (0.4%). 14 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
Navarre Opti Drain	1,301	455	0%	98.2%
Navarre Universal Drain	1,238	335	0%	97.7%
Channel Drain	281	66	0%	86.8%
Blake Si Drain Hbls 10fr Rnd W/ 1/8in	220	22	0%	94.1%
Blake Drain Unknown Product	157	7	6.3%	14.5%
Flexima Catheter	60	0	1.9%	54.1%
Flexima?	7	10	0.4%	75.5%
Round Blake Hubless Silicon Drains - 3/4 Fluted	6	0	0%	51.6%
BLAKE Drain	4	4	1.8%	45.9%
Flexima APDL	4	21	1.1%	69.8%
Vasoview 6 Pro	2	8	0%	94.5%
Catheter	1	9	3.7%	27.9%
Cook	1	6	2.2%	45%
Onestep	1	47	1.8%	86.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
C R Bard Basd -3006260740	2,571	43.7%
Ethicon	255	4.3%
C R Bard Covington -1018233	240	4.1%
Merit Medical Systems	100	1.7%
C R Bard	98	1.7%
Cardinal Health 200	76	1.3%
Productos Para El Cuidado De La Salud -9611590	64	1.1%
Alcon Research - Alcon Precision Device	63	1.1%
Bard Access Systems	57	1%
Cardinal Health	43	0.7%
Maquet Cardiovascular	27	0.5%
Angiodynamics	25	0.4%
Icu Medical Costa Rica	23	0.4%
Hospira	17	0.3%
Medline Industries	8	0.1%

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

Death0.4%26

Injury17.7%1,043

Malfunction81.6%4,803

Other0.2%14

Not given0.1%3

Who filed

Manufacturer report95.5%5,624

Voluntary report2%119

User facility report0%0

Distributor report0%0

Not given2.5%146

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fracturea broken bone	1,515	25.7%
Breakthe device broke	1,102	18.7%
Material separation	750	12.7%
Fluid/blood leak	549	9.3%
Defective component	375	6.4%
Nonstandard device	263	4.5%
Material integrity problema problem with the device material	237	4%
Leak/splashthe device leaked	218	3.7%
Material fragmentation	120	2%
Infusion or flow problema problem with flow or infusion	118	2%
Device contamination with chemical or other material	111	1.9%
Device contaminated during manufacture or shipping	109	1.9%
Difficult to removethe device was hard to remove	105	1.8%
Crackthe device cracked	97	1.6%
Dull, blunt	78	1.3%
Detachment of device component	75	1.3%
Suction problem	64	1.1%
Disconnection	62	1.1%
Replace	61	1%
Deformation due to compressive stress	60	1%

Questions about catheter, irrigation reports

What is product code GBX?

FDA's classification code for "Catheter, irrigation", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,889 reports through August 2026, 1,141 of them in the latest 12 months.

Which brands appear most often?

Navarre Opti Drain (1,301), Navarre Universal Drain (1,238), Channel Drain (281), Blake Si Drain Hbls 10fr Rnd W/ 1/8in (220) and Blake Drain Unknown Product (157). 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.