FDA Adverse Event
Injury
Summary report: N
PORTEX SPINAL ANESTHESIA TRAY
MDR report key: 2833043
·
Received November 5, 2012
Report
- Report Number
- 2183502-2012-00518
- Event Type
- Injury
- Date Received
- November 5, 2012
- Date of Event
- September 18, 2012
- Report Date
- November 1, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- CAZ
- PMA / PMN Number
- K965017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
ACCORDING TO USER FACILITY'S REPORT THE DEVICE WAS I USE WITH A PT AND THE NEEDLE BROKE IN TWO PLACES. ACCORDING TO THE REPORTER, UPON REMOVAL OF DEVICE TWO NEEDLE FRAGMENTS REMAINED IN PT. ACCORDING TO REPORTER THE FRAGMENTS WERE SURGICALLY REMOVED WITH NO FURTHER COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX SPINAL ANESTHESIA TRAY | CAZ - ANESTHESIA CONDUCTION KIT | CAZ | SMITHS MEDICAL ASD, INC. | NA | 1352073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |