BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBRAUN STIFFEN MICRO-INTRODUCER KIT

    MDR report key: 1972693 · Received January 21, 2011

    Report

    Report Number
    MW5019137
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BBRAUN
    Product Code
    BSR
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATH, IT WAS DISCOVERED THAT THE INTRODUCER NEEDLE USED IN INTRODUCER KIT DEVELOPED A FRACTURE IN HUB DURING USE WITH PT. THIS OCCURRED WITH 2 DEVICES FROM SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBRAUN STIFFEN MICRO-INTRODUCER KIT INTRODUCER BSR BBRAUN MPIK-5S-NP7 F0971610
    2 BBRAUN STIFFEN MICRO-INTRODUCER KIT INTRODUCER BSR BBRAUN MPIK-5S-NP7 F0971610

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other