FDA Adverse Event
Death
Summary report: N
TUBE, GASTROINTESTINAL (AND ACCESS)
MDR report key: 1031844
·
Received April 17, 2008
Report
- Report Number
- 2523003-2008-00038
- Event Type
- Death
- Date Received
- April 17, 2008
- Date of Event
- December 28, 2007
- Report Date
- March 25, 2008
- Manufacturer
- CR. BARD, INC. (BASD)
- Product Code
- KNT
- PMA / PMN Number
- K033562
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
PREMATURE DEFLATION OF AN INTERNAL BOLSTER. THE INTERNAL BOLSTER REMAINED IN ABDOMINAL CAVITY. THIS INCIDENT WENT UNNOTICED, AND A NUTRITION SOLUTION WAS ADMINISTERED, WHICH RESULTED IN PATIENT'S DEATH BY PERITONITIS. THE INTERNAL BOLSTER WAS FOUND DEFLATED. THE PATIENT WAS IMMOBILE, THEREFORE, IT WAS UNLIKELY THAT THE PATIENT REMOVED THE INTERNAL BOLSTER HIM/HERSELF. THE INCIDENT WAS FOUND 7 DAYS AFTER PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUBE, GASTROINTESTINAL (AND ACCESS) | KNT | CR. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |