BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP431-01

    MDR report key: 6165412 · Received December 11, 2016

    Report

    Report Number
    3010293992-2016-00282
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Report Date
    May 9, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FPA
    UDI-DI
    17290109150519
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    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: ADMINISTRATION SET LEAKAGE OF CHEMOTHERAPY.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "PER CLINICAL DEPARTMENT, THE ISSUE IS SLIT ON TUBING AT SLIDER CLAMP AREA- 12000-000-0027- AP431-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE, 2 NEEDLELESS Y-SITE INJURIES OR ADVERSE EVENT: NO; ITEM: (B)(4); QUANTITY AFFECTED: 1 EACH; SERIAL/LOT NUMBER: N/A; PO #: (B)(4); ARE ANY SAMPLES AVAILABLE FOR RETURN? NO. THIRTY (30) CC LEAKS FROM TUBING TO FLOOR IN PT ROOM, NO HUMAN HARMED, SPLASH OF CHEMO COLORING UNTO RN SHOE. DEATH/SERIOUS INJURY: NO, HUMAN HARM: NO, DELAY IN THERAPY: NO, MEDICAL INTERVENTION NEEDED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815857 AP431-01 ADMINISTRATION SET FPA Q CORE MEDICAL LTD. 17290109150519

    Patients

    Seq Age Sex Outcome Treatment
    1