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