BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET

    MDR report key: 1770957 · Received July 27, 2010

    Report

    Report Number
    6000001-2010-01966
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERLINK CONTINU-FLO 4-WAY STOPCOCK WHICH WAS LEAKING ON BOTH SIDES OF THE STOPCOCKS DURING PATIENT USE. THE DEVICE BEGAN LEAKING AFTER BEING USED FOR TWO HOURS BY AN UNKNOWN PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1