BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO AVF SET

    MDR report key: 84747 · Received April 16, 1997

    Report

    Report Number
    1118880-1997-00089
    Event Type
    Injury
    Date Received
    April 16, 1997
    Report Date
    March 17, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH PRODUCT MET IN-PROCESS AND FINISHED DEVICE SPECIFICATIONS, THE FACTORY FURTHER INVESTIGATED MINIMIZATION OF SEEPAGE. A NEEDLE FINISHING PROCESS WAS MODIFIED TO EFFECT LESS SEEPAGE. THE NEEDLES MFR WAS THIS MODIFIED PROCESS ALSO MEET ALL THE ORIGINAL IN-PROCESS SPECIFICATIONS AND FINISHED DEVICE SPECIFICATIONS. PRODUCT SPECIFICATIONS WERE NOT CHANGED.

    Description of Event or Problem · 1

    PAINFUL INSERTION AND LEAKING AT ACCESS SITE. LARGE AMOUNT OF AND PROLONGED BLEDDING, HAD TO USE GAUZE AND GELFOAM TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP. NA TK2451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention