Apparatus, suction, single patient use, portable, nonpowered: medical device reports filed with FDA

4,711 reports carry this product code, 1992–2026; 16 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.

4,711
reports with this product code: 0% of all MAUDE reports; 138
reports, 12 months to August 2026: 161 in the 12 months before; 61%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code GCY is FDA's classification for "Apparatus, suction, single patient use, portable, nonpowered" (general, Plastic Surgery panel), a class 1 device. 4,711 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

138 reports arrived in the 12 months to August 2026, down 14% from 161 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 (61%), injury (34.1%) and other (3.4%). 16 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
J-VAC Reservoir	538	16	0.4%	86.1%
BLAKE Drain	499	4	1.8%	45.9%
Closed Wound Suction	286	80	0%	93%
Cws 400 Closed Wound Suction Kit Pvc Drain	174	0	0%	88.6%
Ivt Disposable	44	0	0%	99.7%
Baxter	7	3	3.8%	54.2%
Zimmer	7	0	2.8%	17.2%
Tbd	4	8	0.6%	72.7%
Argyle	3	60	1%	82.4%
Endo Gia Universal Xl	2	0	1.8%	7.9%
Ni	2	1,587	1.8%	29.5%
Bard	1	2	1.8%	31.1%
Cardinal Health	1	185	0.2%	89.8%
Endopouch Retriever Spec Bag	1	35	0%	95%
Medline	1	26,184	0.1%	97.9%
Stryker	1	5	1.3%	46.3%

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	907	19.3%
Ethicon	829	17.6%
C R Bard	266	5.6%
Allegiance Healthcare	249	5.3%
Cardinal Health	231	4.9%
Productos Para El Cuidado De La Salud -9611590	169	3.6%
Baxter Healthcare - Cleveland	97	2.1%
Davol	57	1.2%
Zimmer Surgical	43	0.9%
Zimmer	35	0.7%
Cardinal Health 200	34	0.7%
Medline Industries	27	0.6%
Bard	22	0.5%
Baxter Healthcare	17	0.4%
Davol Sub C R Bard	6	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

Death0.3%13

Injury34.1%1,608

Malfunction61%2,874

Other3.4%161

Not given1.2%55

Who filed

Manufacturer report76.5%3,605

Voluntary report7.5%353

User facility report0%0

Distributor report0.9%44

Not given15%709

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,480	31.4%
Difficult to removethe device was hard to remove	659	14%
Disconnection	299	6.3%
Suction problem	265	5.6%
Explanted	236	5%
Tears, rips, holes in device, device material	223	4.7%
Detachment of device component	209	4.4%
Device, or device fragments remain in patient	187	4%
Air leak	175	3.7%
Other (for use when an appropriate device code cannot be identified)	172	3.7%
Material separation	167	3.5%
Replace	152	3.2%
Device, removal of (non-implant)	149	3.2%
Inflation problem	118	2.5%
Device contamination with chemical or other material	114	2.4%
Dull, blunt	110	2.3%
Material fragmentation	106	2.3%
Fracturea broken bone	104	2.2%
Suction failure	102	2.2%
Fluid/blood leak	88	1.9%

Questions about apparatus, suction, single patient use, portable, nonpowered reports

What is product code GCY?

FDA's classification code for "Apparatus, suction, single patient use, portable, nonpowered", 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?

4,711 reports through August 2026, 138 of them in the latest 12 months.

Which brands appear most often?

J-VAC Reservoir (538), BLAKE Drain (499), Closed Wound Suction (286), Cws 400 Closed Wound Suction Kit Pvc Drain (174) and Ivt Disposable (44). 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.