BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPS SINGLE ACTION PUMP

    MDR report key: 5917004 · Received August 31, 2016

    Report

    Report Number
    5917004
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A SINGLE ACTION SYRINGE PUMP WAS DEFECTIVE; IT WAS NOT WORKING AND DOING WHAT IT WAS SUPPOSED TO BE DOING. MANUFACTURER RESPONSE FOR ACTION PUMP SYRINGE, BOSTON SCIENTIFIC ACTION PUMP SYRINGE (PER SITE REPORTER): COMPANY REP COMING TO PICK IT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570000 SAPS SINGLE ACTION PUMP CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION M0067201001 18810562

    Patients

    Seq Age Sex Outcome Treatment
    1