MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; NERVE BLOCK TRAY

Model Number 332100

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

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.

• Brand Name: B.BRAUN
• Type of Device: NERVE BLOCK TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 10051237
• MDR Text Key: 190772902
• Report Number: 10051237
• Device Sequence Number: 1
• Product Code: OGJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 332100
• Device Catalogue Number: 332100
• Device Lot Number: 0061707901
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1