MalfunctionOGJ
B.BRAUN
Received May 13, 2020 · Event occurred Mar 4, 2020
Report 10051237 · MDR key 10051237
Device
Generic name
Nerve Block Tray
Manufacturer
B. Braun Medical Inc.Model number
332100Catalog number
332100
Lot number
0061707901
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
5CC PLASTIC SYRINGE (CONTAINED IN B BRAUN NERVE BLOCK SUPPORT TRAY LOT #0061707901, 2022-08-31, GTIN (B)(4)) WAS FOUND TO CONTAIN WHAT APPEARED TO BE A (BLACK) PARTICLE OF STOPPER. THE PRESENCE OF THIS PARTICLE WAS OBSERVED BY PHYSICIAN PRIOR TO ADMINISTRATION, WHEN TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION (LOT #AP190190, EXP 08/2021, NDC (B)(4)) WAS DRAWN INTO 5CC PLASTIC SYRINGE. SYRINGE WAS PROMPTLY REPLACED PRIOR TO PROCEDURE.