BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS IV SET

    MDR report key: 1943997 · Received December 3, 2010

    Report

    Report Number
    3005789918-2010-00031
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FPA
    PMA / PMN Number
    K830755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING DIFFICULTY WITH THE (B)(4). THE TUBING LEAKED WHERE THE LONG TUBING PIECE FROM THE IV BAG SCREWS ON (LUER LOCK) TO THE PIG TAIL PIECE. IT APPEARED THERE WAS A CRACK IN THE BEGINNING PIECE OF THE PIGTAIL (HARD PLASTIC) NOT THE FLEXIBLE TUBING. ADDITIONAL INFO RECEIVED FROM THE SALES REP ON (B)(6) 2010 STATED THE IV WAS PLACED IN THE PT. THE PHYSICIAN ATTEMPTED TO INDUCE MEDICATION, AT WHICH TIME A LEAK WAS NOTICED IN THE TUBING. ACCORDING TO THE PHYSICIAN THERE WAS ACTUALLY PIN HOLES IN THE TUBING WHICH CAUSED SIGNIFICANT LEAKING. AS A RESULT, THE SET WAS EXCHANGED FOR THE PT. THERE WAS MINIMAL TIME OF INTERRUPTION IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS IV SET WALRUS PRODUCTS FPA ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN