FDA Adverse Event
Malfunction
Summary report: N
PERIFIX FX CONTINUOUS EPIDURAL CATHETER
MDR report key: 3032114
·
Received March 13, 2013
Report
- Report Number
- 3032114
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- B.BRAUN MEDICAL, INC.
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STAFF NOTICED THAT THE INK MARKINGS WERE COMING OFF THE EPIDURAL CATHETERS. THE CONCERN WAS REPORTED TO THE MANUFACTURER AND BRAUN REPRESENTATIVES SAID THAT THE INK IS BIO-COMPATIBLE AND THAT IT IS MORE OF A QUALITY ISSUE. STAFF SAVED 3 CATHETERS BUT SAID THEY NOTICED THIS WAS HAPPENING ON MANY OTHER CATHETERS FROM 3 SEPARATE BATCH NUMBERS. PRODUCT 332097 3 BATCHES HAD ISSUE 0061287412---0061287476-----0061242123.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EPIDURAL CATHETER PLACEMENT AND MANAGEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106536 | PERIFIX FX CONTINUOUS EPIDURAL CATHETER | ANESTHESIA CONDUCTION KIT | CAZ | B.BRAUN MEDICAL, INC. | 2014-05 | 0061287476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |