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 |