FDA Adverse Event
Other
Summary report: N
SILCON THORACIC CATH 28FR
MDR report key: 2729326
·
Received August 30, 2012
Report
- Report Number
- 1282497-2012-00020
- Event Type
- Other
- Date Received
- August 30, 2012
- Date of Event
- July 22, 2012
- Report Date
- August 1, 2012
- Manufacturer
- COVIDIEN
- Product Code
- GBS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE 08/30/2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A THORACIC CATHETER. THE CUSTOMER REPORTED, UPON REMOVAL OF THE DEVICE FROM THE PT'S CHEST, IT WAS NOTED THAT A PIECE OF THE DEVICE WAS MISSING. AFTER AN X-RAY, IT WAS CONFIRMED THAT A 15 CM PIECE OF THE DEVICE REMAINED IN THE PT. A THORACOTOMY PROCEDURE WAS DONE TO REMOVE THE CATHETER PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILCON THORACIC CATH 28FR | THORACIC CATHETER | GBS | COVIDIEN | 8888572552 | U1290355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |