BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO AVF SET

    MDR report key: 95260 · Received May 30, 1997

    Report

    Report Number
    1118880-1997-00131
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Report Date
    May 1, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NEEDLE SEPARATED AT HUB. NO TRAUMA INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP. NA UE0151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN