BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS STOPCOCK AND MANI FOLD COMPONENT

    MDR report key: 1230384 · Received November 7, 2008

    Report

    Report Number
    3005789918-2008-00014
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FMG
    PMA / PMN Number
    K830755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE STOPCOCK IS USED IN THEIR NEONATAL INTENSIVE CARE UNIT. THE STOPCOCK WAS IN PLACE WHEN THEY NOTICED IT TO BE CRACKED AND LEAKING BLOOD. AS A RESULT, THE STOPCOCK WAS EXCHANGED. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS STOPCOCK AND MANI FOLD COMPONENT WALRUS PRODUCTS FMG ARROW INTERNATIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK