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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 (KIT)

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B. BRAUN MEDICAL INC. B.BRAUN NERVE BLOCK TRAY (KIT) Back to Search Results
Model Number 332100
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
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.

 
Event Description

Per medwatch number: (b)(4). Event description: 5cc plastic syringe 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 was drawn into 5cc plastic syringe. No injury reported.

 
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Brand NameB.BRAUN
Type of DeviceNERVE BLOCK TRAY (KIT)
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, pa 
7197287
MDR Report Key10132696
MDR Text Key194537640
Report Number2523676-2020-00156
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number332100
Device Catalogue Number332100
Device LOT Number0061707901
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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