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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. NERVE BLOCK TRAY Back to Search Results
Model Number 570258
Device Problem Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 03/04/2021
Event Type  Malfunction  
Event Description

While trying to secure the needle in the needle block foam holder that comes with the tray, the needle easily pushed thru the bottom of the holder. There is potential for blood exposure from used needle.

 
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Brand NameNERVE BLOCK TRAY
Type of DeviceNERVE BLOCK TRAY
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
MDR Report Key11494739
MDR Text Key240100514
Report Number11494739
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/08/2021,03/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number570258
Device Catalogue Number570258
Device LOT Number0061719165
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2021
Event Location AMBULATORY SURGICAL Facility
Date Report TO Manufacturer03/16/2021
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? No
Type of Device Usage Unkown

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