FDA Adverse Event
Death
Summary report: N
PER-Q-CATH PICC
MDR report key: 378285
·
Received February 22, 2002
Report
- Report Number
- 1720496-2002-00027
- Event Type
- Death
- Date Received
- February 22, 2002
- Date of Event
- December 29, 2001
- Report Date
- January 30, 2002
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
CARDIAC TAMPONADE, RESULTING IN DEATH. PICC LINE WAS INSERTED VIA RIGHT ANTECUBITAL FOSSA AND LOCATION WAS CONFIRMED BY X-RAY. APPROX. 3 HOURS LATER, WHEN 10 CC OF TPN HAD BEEN ADMINISTERED, THE PT ARRESTED AND COULD NOT BE RESUSCITATED. AUTOPSY SHOWED PERICARDIAL TAMPONADE WITH LIKELY PERFORATION SITE BY THE PICC INTO THE ANTERIOR RIGHT VENTRICLE. REPORTED BY MEDWATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PER-Q-CATH PICC | LONG TERM INTRAVENOUS ACCESS DEVICE | DQO | BARD ACCESS SYSTEMS | UNK | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |