FDA Adverse Event
Malfunction
Summary report: N
BLAKE DRAIN
MDR report key: 1962935
·
Received December 22, 2010
Report
- Report Number
- 2210968-2010-01713
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 24, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- KOG
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A ROSS OPEN HEART PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS PLACED AND CONNECTED TO A PLEUROVAC. ON (B)(6) 2010, AN AIR LEAK WAS NOTED WITH A CUT/SLIT FOUND ON THE DRAIN. THE DAMAGED PORTION OF THE DRAIN WAS CUT OFF AND THE DRAIN WAS REATTACHED TO THE PLEUROVAC. THERE WAS NO KNOWN ADVERSE PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLAKE DRAIN | WOUND DRAINAGE SYSTEM | KOG | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 MO |