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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
Catalog Number 332100
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

This report has been identified as b. Braun medical internal report number (b)(4). As reported by the user facility, it was confirmed that the batch number was unknown and the sample was not available for further evaluation. Without the actual device and/or lot number, a thorough investigation could not be performed. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

 
Event Description

As reported by the user facility: event 1: complaint: customer stated the syringes in the peripheral nerve block support tray had "condensation" in them. They appeared "cloudy". 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 18109
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key8148467
MDR Text Key130329578
Report Number2523676-2018-00100
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,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number332100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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