BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS STOPCOCK AND MANI FOLD COMPONENT

    MDR report key: 1170221 · Received September 11, 2008

    Report

    Report Number
    3005789918-2008-00008
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 11, 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

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY HAVE HAD TWO INSTANCES WHERE THE 4-GANG STOPCOCK LEAKED WHILE INFUSING INTO NEONATAL PATIENTS. THERE HAVE BEEN NO PATIENT 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 GF7121983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK