Device brand name · Catheter irrigation

Blake Si Drain Hbls 10fr Rnd W/ 1/8in: medical device reports filed with FDA

220 reports name it, 2022–2026. Manufacturer given most often on reports: Ethicon. Product code GBX.

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.

220
device reports naming the brand: 0% of all MAUDE reports · about 52 a year; 22
reports, 12 months to August 2026: 137 in the 12 months before; 94.1%
classified as malfunction: 81.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 220 reports that name the brand "Blake Si Drain Hbls 10fr Rnd W/ 1/8in" (catheter irrigation), received between April 2022 and March 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.

22 reports arrived in the 12 months to August 2026, down 84% from 137 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 (94.1%) and injury (5.9%); across all catheter, irrigation reports (product code GBX) death is recorded in 0.4% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material integrity problem (42.3%), leak/splash (25.5%) and break (11.4%). The patient problems coded most often are foreign body in patient, hematoma and seroma. 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

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

Event type and report source

Event type, as classified on the report

Death0%0

Injury5.9%13

Malfunction94.1%207

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%220

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 5,889 reports carrying product code GBX. 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
Material integrity problema problem with the device material	93	42.3%	4%
Leak/splashthe device leaked	56	25.5%	3.7%
Breakthe device broke	25	11.4%	18.7%
Device contaminated during manufacture or shipping	25	11.4%	1.9%
Infusion or flow problema problem with flow or infusion	24	10.9%	2%
Component missing	1	0.5%	0.3%
Difficult to open or remove packaging material	1	0.5%	0%

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
Foreign body in patientpart of a device left in the patient	7	3.2%
Hematomaa collection of blood under the skin or in tissue	3	1.4%
Seromaa collection of fluid under the skin	3	1.4%
Hemorrhage/blood loss/bleeding	2	0.9%
Swelling/ edema	1	0.5%

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

In context

Measure	Blake Si Drain Hbls 10fr Rnd W/ 1/8in	Product code GBX	All MAUDE reports
Reports	220	5,889	26,136,888
Share of that pool	—	3.7%	0%
Classified as death, per 1,000 reports	0	4	9
Classified as injury	5.9%	17.7%	36.2%
Classified as malfunction	94.1%	81.6%	62.3%
Filed by the manufacturer	100%	95.5%	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 GBX

Brand	Reports	Latest 12 months	Classified as death
Navarre Opti Drain	1,301	455	0%
Navarre Universal Drain	1,238	335	0%
Channel Drain	281	66	0%
Blake Drain Unknown Product	159	7	6.3%
Flexima Catheter	157	0	1.9%
Flexima?	257	10	0.4%
Round Blake Hubless Silicon Drains - 3/4 Fluted	184	0	0%
BLAKE Drain	738	4	1.8%
Flexima APDL	268	21	1.1%
Vasoview 6 Pro	328	8	0%
Catheter	244	9	3.7%
Cook	271	6	2.2%
Onestep	167	47	1.8%

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 Blake Si Drain Hbls 10fr Rnd W/ 1/8in reports

How many FDA reports name Blake Si Drain Hbls 10fr Rnd W/ 1/8in?

220 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.

What kinds of events are reported?

malfunction (94.1%) and injury (5.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material integrity problem (42.3%), leak/splash (25.5%), break (11.4%), device contaminated during manufacture or shipping (11.4%) and infusion or flow problem (10.9%). 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 Blake Si Drain Hbls 10fr Rnd W/ 1/8in 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.