Devices › Apparatus, suction, single patient use, portable, nonpowered
Device brand name · Closed wound suction kit
Cws 400 Closed Wound Suction Kit Pvc Drain: medical device reports filed with FDA
175 reports name it, 2014–2023. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code GCY.
- 175
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.6%
- classified as malfunction
- 61% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
175 medical device reports received by FDA name the brand "Cws 400 Closed Wound Suction Kit Pvc Drain" (closed wound suction kit); the manufacturer given most often on reports is C R Bard Covington -1018233; received from August 2014 to July 2023. 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 (88.6%) and injury (11.4%); across all apparatus, suction, single patient use, portable, nonpowered reports (product code GCY) death is recorded in 0.3% and malfunction in 61%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are dull, blunt (41.7%), disconnection (18.3%) and material fragmentation (9.1%). The patient problems coded most often are foreign body in patient, appropriate clinical signs, symptoms and conditions term/code not available and injury. 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
Who filed the report
Grey bar: all 4,711 reports carrying product code GCY. 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 |
|---|---|---|---|
| Dull, blunt | 73 | 41.7% | 2.3% |
| Disconnection | 32 | 18.3% | 6.3% |
| Material fragmentation | 16 | 9.1% | 2.3% |
| Suction failure | 12 | 6.9% | 2.2% |
| Breakthe device broke | 8 | 4.6% | 31.4% |
| Fluid/blood leak | 7 | 4% | 1.9% |
| Fitting problem | 5 | 2.9% | 0.4% |
| Detachment of device or device componentpart of the device came off | 2 | 1.1% | 1.6% |
| Difficult to insertthe device was hard to insert | 2 | 1.1% | 0.2% |
| Leak/splashthe device leaked | 2 | 1.1% | 1.4% |
| Loose or intermittent connection | 2 | 1.1% | 0.2% |
| Material separation | 2 | 1.1% | 3.5% |
| Material split, cut or torn | 2 | 1.1% | 0.7% |
| Material twisted/bent | 2 | 1.1% | 0.1% |
| Complete blockage | 1 | 0.6% | 0.4% |
| Component misassembled | 1 | 0.6% | 0.3% |
| Deformation due to compressive stress | 1 | 0.6% | 0% |
| Device contamination with chemical or other material | 1 | 0.6% | 2.4% |
| Difficult to open or close | 1 | 0.6% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.6% | 14% |
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 | 16 | 9.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 2.9% |
| Injurya physical injury | 3 | 1.7% |
| Bruise/contusion | 2 | 1.1% |
| Device embedded in tissue or plaque | 2 | 1.1% |
| Irritationirritation | 2 | 1.1% |
| No patient involvement | 2 | 1.1% |
| Painpain, site not specified | 1 | 0.6% |
| Skin irritationirritated skin | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cws 400 Closed Wound Suction Kit Pvc Drain | Product code GCY | All MAUDE reports |
|---|---|---|---|
| Reports | 175 | 4,711 | 26,136,888 |
| Share of that pool | — | 3.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 11.4% | 34.1% | 36.2% |
| Classified as malfunction | 88.6% | 61% | 62.3% |
| Filed by the manufacturer | 100% | 76.5% | 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 GCY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| J-VAC Reservoir | 719 | 16 | 0.4% |
| BLAKE Drain | 738 | 4 | 1.8% |
| Closed Wound Suction | 286 | 80 | 0% |
| Ivt Disposable | 4,238 | 0 | 0% |
| Baxter | 821 | 3 | 3.8% |
| Zimmer | 1,159 | 0 | 2.8% |
| Tbd | 622 | 8 | 0.6% |
| Argyle | 871 | 60 | 1% |
| Endo Gia Universal Xl | 165 | 0 | 1.8% |
| Ni | 32,939 | 1,587 | 1.8% |
| Bard | 1,124 | 2 | 1.8% |
| Cardinal Health | 589 | 185 | 0.2% |
| Endopouch Retriever Spec Bag | 734 | 35 | 0% |
| Medline | 26,935 | 26,184 | 0.1% |
| Stryker | 559 | 5 | 1.3% |
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." 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 Cws 400 Closed Wound Suction Kit Pvc Drain reports
How many FDA reports name Cws 400 Closed Wound Suction Kit Pvc Drain?
175 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 (88.6%) and injury (11.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
dull, blunt (41.7%), disconnection (18.3%), material fragmentation (9.1%), suction failure (6.9%) and break (4.6%). 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 Cws 400 Closed Wound Suction Kit Pvc Drain 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.