BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO AVF SET

    MDR report key: 95247 · Received May 30, 1997

    Report

    Report Number
    1118880-1997-00135
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Report Date
    May 2, 1997
    Manufacturer
    TERUMO MEDICAL CORP. (MD) EAST
    Product Code
    FIE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAKAGE AT THE INSERTION SITE. IT WAS ALSO REPORTED, TERUMO'S NEEDLE WERE DULL AND THE NEEDLES SLIDE OUT ONCE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP. (MD) EAST NA UE2251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN