PERIFIX®
Received Apr 20, 2026 · Event occurred Apr 3, 2026
Report 2521402-2026-00405 · MDR key 24924583
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical Inc.Catalog number
332079
Lot number
0062048547
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: SEVERAL CRNAS HAVE REPORTED AT LEAST 3 CATHETER DISCONNECTS OR BROKEN CATHETERS. IT IS UNCLEAR IF THE CATHETER SLIPPED OUT OF THE CONNECTOR OR IF THE CATHETER BROKE OFF. AT LEAST ONE INCIDENT REPORTED WHERE CATHETER "BROKE" AND A PIECE OF THE CATHETER REMAINED IN THE CONNECTOR. IN ADDITION, A CRNA OPENED A TRAY (332079) LOT 0062048547 AND APPLIED GENTLE/CONSTANT PULL TO THE CATHETER ON BOTH ENDS RESULTING IN THE CATHETER TO SNAP AND COME APART.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.