FDA Adverse Event Malfunction Summary report: N

PORTEX CONTINUOUS EPIDURAL TRAY

MDR report key: 3130984 · Received February 12, 2013

Report

Report Number
2183502-2013-00023
Event Type
Malfunction
Date Received
February 12, 2013
Manufacturer
SMITHS MEDICAL MD, INC.
Product Code
CAZ
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE INVESTIGATION.

Description of Event or Problem · 1

REF IMP REPORT: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
62718 PORTEX CONTINUOUS EPIDURAL TRAY CAZ-ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL MD, INC.

Patients

Seq Age Sex Outcome Treatment
1