FDA Adverse Event
Death
Summary report: N
TITANIUM LOW PROFILE IMPLANTED PORT W/ATTACH 8.0 FR GROSHONG S
MDR report key: 1658013
·
Received April 9, 2010
Report
- Report Number
- 3006260740-2010-00080
- Event Type
- Death
- Date Received
- April 9, 2010
- Date of Event
- March 12, 2010
- Report Date
- March 17, 2010
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJT
- PMA / PMN Number
- K050310
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
THE CATHETER WAS IMPLANTED WITHOUT REMOVING THE STIFFENER STYLET. THE INDWELLING PERIOD WAS 186 DAYS. THE PT WAS SUFFERING CARDIOPULMONARY ARREST ON ARRIVAL AND THE PT'S DEATH WAS CONFIRMED LATER. THE UN-REMOVED STYLET WAS FOUND BY X-RAY. THE STYLET PUNCTURED THE RIGHT ATRIUM AND REACHED LIVER. THE AUTOPSY CONCLUDED THAT THIS PUNCTURE BY THE STYLET WAS THE CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITANIUM LOW PROFILE IMPLANTED PORT W/ATTACH 8.0 FR GROSHONG S | LJT | C. R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |