BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28 GA SPLITTABLE NEEDLE INTRODUCER PICC KIT

    MDR report key: 5093525 · Received September 22, 2015

    Report

    Report Number
    5093525
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 14, 2015
    Manufacturer
    ARGON MEDICAL DEVICES INC
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLACING A PICC ON A CRITICALLY ILL PATIENT. WHEN NEEDLE INTRODUCED, BLOOD RETURN NOTED QUICKLY COMING FROM SIDES OF SPLITTABLE NEEDLE. THE NEEDLE WAS SPLIT ON PLASTIC TO METAL NEEDLE PART WHEN INTRODUCED INTO VEIN ENOUGH TO HAVE THE BLOOD RETURN COME OUT THE SIDES OF NEEDLE RATHER THAN THE END. UNABLE TO THREAD CATHETER THROUGH NEEDLE. NEEDLE WITHDRAWN AND UNABLE TO PLACE PICC. NEW SITE ATTEMPTED WITH THE SAME TROUBLE WITH SPLITTABLE NEEDLE. UNDERSIDE OF NEEDLE SPLIT ON PLASTIC TO METAL PART. ABLE TO ADVANCE THIS CATHETER FOR SUCCESSFUL PLACEMENT OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626855 28 GA SPLITTABLE NEEDLE INTRODUCER PICC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC 11100941

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR