BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 PORT MANIFOLD

    MDR report key: 4946109 · Received July 28, 2015

    Report

    Report Number
    0001811755-2015-02748
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 16, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K132671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY USER, NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE BECAME CLOGGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489104 4 PORT MANIFOLD APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1