FDA Adverse Event
Injury
Summary report: N
BD PERISAFE
MDR report key: 1964052
·
Received January 11, 2011
Report
- Report Number
- 2618282-2011-00001
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 13, 2010
- Report Date
- January 11, 2011
- Manufacturer
- BECTON DICKINSON
- Product Code
- CAZ
- PMA / PMN Number
- K012584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE USER WAS PERFORMING BIRTH ANAESTHESIA WITH EPIDURAL METHOD. THEY REMOVED TUHOY NEEDLE AND THEY PERFORMED AN ASPIRATION TEST FOR BLOOD REFLUX. THEY DECIDED TO PLACE A NEW DEVICE REMOVING THE ONE IN USE. AFTER WITHDRAWING THE DEVICE THEY SAW THAT A PART, 5 CM IN LENGTH, WAS MISSING. THE DIAGNOSTIC PROCEDURE WAS STARTED. THE USER WILL PERFORM A MEDICAL INTERVENTION UNDER LOCAL ANAESTHESIA TO REMOVE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD PERISAFE | EPIDURAL MINI-KIT | CAZ | BECTON DICKINSON | NA | 9222384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |