BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP431-01 HCR

    MDR report key: 6049576 · Received October 23, 2016

    Report

    Report Number
    3010293992-2016-00237
    Event Type
    Malfunction
    Date Received
    October 23, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FPA
    UDI-DI
    17290109150519
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "IV SETTING LEAKING ABOVE UPPER BACK CHECK VALVE".

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "IV SETTING LEAKING ABOVE UPPER BACK CHECK VALVE - ADMINISTRATION SET TYPE: 12000-000-0027- AP431-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE, 2 NEEDLELESS Y-SITE, WAS THERE A PRIME PERFORMED:YES, PUMP OR MANUAL: MANUAL. HUMAN HARM: NO, DELAY IN THERAPY: NO, MEDICAL INTERVENTION NEEDED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700790 AP431-01 HCR ADMINISTRATION SET FPA Q CORE MEDICAL LTD. 16385-01 17290109150519

    Patients

    Seq Age Sex Outcome Treatment
    1