BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRO SAFETRAC 28CM

    MDR report key: 3177915 · Received June 12, 2013

    Report

    Report Number
    MW5030578
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D ON (B)(6) 2013: (B)(4). BARD ACCESS SYSTEMS IS THE CORRECT MFR OF THE PRODUCT AND NOT SPIRE BIOMEDICAL INC. THERE ARE NO OTHER CHANGES. WHEN REMOVING THE TUNNELER FROM PT, THE WHITE CAP ON THE TUNNELING DEVICE BROKE OFF INTO THE PT. DISLODGED PIECE WAS SUCCESSFULLY RETRIEVED BY SURGEON. X-RAY CONFIRMED NO RETAINED OBJECTS.

    Description of Event or Problem · 1

    WHEN REMOVING THE TUNNELER FROM PT THE WHITE CAP ON THE TUNNELING DEVICE BROKE OFF INFO THE PT. DISLODGED PIECE WAS SUCCESSFULLY RETRIEVED BY SURGEON. X-RAY CONFIRMED NO RETAINED OBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266278 RETRO SAFETRAC 28CM LONG TERM HEMODIALYSIS CATH MSD BARD ACCESS SYSTEMS 99747723

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR