FDA Adverse Event
Injury
Summary report: N
SAFETY-T CENTESIS CATHETER DRAINAGE TRAY
MDR report key: 1133203
·
Received August 22, 2008
Report
- Report Number
- 1423507-2008-00066
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 18, 2008
- Manufacturer
- CARDINAL HEALTH
- Product Code
- GCB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO HAS BEEN FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. RESULTS PENDING. A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
BLUNT OBTURATOR IS STICKING AND REPORTEDLY PERFORATED THE PT'S LUNG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFETY-T CENTESIS CATHETER DRAINAGE TRAY | SAFETY-T CENTESIS CATHETER DRAINAGE TRAY | GCB | CARDINAL HEALTH | PIG1260T | L8H239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |