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.
[183949452]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183949453]
It was reported that the drain pulled apart at the "y" connection. The complainant noted that the drain did not keep pressure for suction. The writer attempted to reseat and make sure all connections on the drain and at the y connector were hooked in correctly. Several attempts reportedly failed. The nurse reportedly looked at the site where the drain tubing entered the patient's back, and a "hissing" noise could be heard when attempting to depress the drain. They were unable to see any damage to the tubing. The suture remained intact, and did not appear to be pulled out at the time. The nurse was reportedly advised to pull the drain. The drain was reportedly in use for 16 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01102 |
| MDR Report Key | 9722529 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-03-19 |
| 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 |
| Returned To Mfg | 2020-02-05 |
| Catalog Number | 0043610 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |