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 2020-03-17 for CWS 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.) 0043660 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183743236]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[183743237]
It was reported that while attempting to remove the drain from the patient's left buttock, the drain tubing broke. The tubing remained inside of the patient. And additional surgery was scheduled for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01856 |
| MDR Report Key | 9841630 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-05-07 |
| Date Added to Maude | 2020-03-17 |
| 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 400ML EVACUATOR KIT WITH 1/8" (3.2MM 10 FR.) |
| Generic Name | CWS 400 KIT |
| Product Code | GCY |
| Date Received | 2020-03-17 |
| Catalog Number | 0043660 |
| Lot Number | NGDQ2620 |
| 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 | 1. Required No Informationntervention | 2020-03-17 |