MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-18 for CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN 0043610 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183943799]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[183943800]
It was reported that drainage was observed to be coming from the insertion site of the accordion drain. The md was notified and it was noted that the drain came apart, and the tubing disconnected from the actual tube, not the y-site. Patient stated he felt it happened when he tried to role in bed. The tube was cleansed and reconnected, and was set back to suction and appeared to be working properly. The drain was reportedly in use for 13 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01093 |
| MDR Report Key | 9721744 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN |
| Generic Name | WOUND DRAIN |
| Product Code | GCY |
| Date Received | 2020-02-18 |
| Catalog Number | 0043610 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |