FDA Adverse Event
Other
Summary report: N
BD EPIDURAL ANESTHESIA TRAY
MDR report key: 2571201
·
Received May 4, 2012
Report
- Report Number
- 2243072-2012-00005
- Event Type
- Other
- Date Received
- May 4, 2012
- Date of Event
- April 6, 2012
- Report Date
- May 4, 2012
- Manufacturer
- BD
- Product Code
- CAZ
- PMA / PMN Number
- PRE-AMEN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN REC'D TO DATE. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
THE DOCTOR MET THE RESISTANCE WHILE INJECTING THE NEEDLE INTO PT FOR EPIDURAL ANESTHESIA. AFTER HE REMOVED THE CATHETER TUBE AND FOUND THAT CATHETER WAS BROKEN. HE COMPARED THE AFFECTED PRODUCT WITH NEW ONE AND FOUND THE USED CATHETER SHORTEN ABOUT 4 CM. THE PT WAS TAKEN FOR CT SCAN AND ENDOSCOPIC INTO PUNCTURE AREA. BROKEN CATHETER WAS NOT FOUND. NO FURTHER ACTIONS WERE TAKEN BY DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD EPIDURAL ANESTHESIA TRAY | EPIDURAL ANESTHESIA TRAY | CAZ | BD | 1262154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |