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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. B.BRAUN NERVE BLOCK TRAY Back to Search Results
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.

 
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Brand NameB.BRAUN
Type of DeviceNERVE BLOCK TRAY
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th ave
bethlehem PA 18018
MDR Report Key10051237
MDR Text Key190772902
Report Number10051237
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number332100
Device Catalogue Number332100
Device LOT Number0061707901
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2020
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer05/13/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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