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 2020-03-03 for CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR 072227 manufactured by C.r. Bard, Inc. (covington) -1018233.
[185074741]
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
[185074742]
It was reported that the trocar broke off. Per additional information received via email on 20feb2020, the trocar detached from the drain prematurely during the pull through the skin. It had been reported to happen every time the drain was used, and the surgeon then had to fish the drain through the trocar hole with an instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01479 |
| MDR Report Key | 9780449 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-03 |
| 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 | CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR |
| Generic Name | WOUND DRAIN |
| Product Code | GBX |
| Date Received | 2020-03-03 |
| Catalog Number | 072227 |
| 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 | 2020-03-03 |