DESIGN OPTIONS®
Received Jul 21, 2026 · Event occurred Jul 13, 2026
Report 2521402-2026-00733 · MDR key 25891070
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical Inc.Catalog number
555098
Lot number
0062061885
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY:DURING SUBCUTANEOUS ADIPOSE TISSUE INFILTRATION (BMI 39) PHYSICIAN MADE A SKIN WHEAL AND THEN INSERTED DIRECTLY INTO SUBQ PERPENDICULAR TO BACK, WITHDREW THE NEEDLE UNTIL OUT OF THE SKIN AND ANGLED CEPHALAD AND HUBBED THE NEEDLE IN THAT TRAJECTORY. AFTER WITHDRAWING THE SYRINGE AFTER THAT MOTION, THE NEEDLE WAS GONE.' THERE WAS NO BENDING OF THE NEEDLE PRIOR OR DURING PROCEDURE. NEEDLE WAS THEN REMOVED SURGICALLY UNDER GENERAL ANESTHESIA.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL NUMBER (b)(4).THE INVESTIGATION IS ONGOING AT THIS TIME.A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.