BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP402-01 HCR - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE

    MDR report key: 5516136 · Received March 22, 2016

    Report

    Report Number
    3010293992-2016-00102
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Report Date
    May 28, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE (B)(4) WAS REPORTED BY A CUSTOMER FROM USA: "ADMINISTRATION SET TYPE: 12004-000-0008. THE END OF THE TUBE IS LEAKING WHERE IS SUPPOSED NOT TO LEAK. FIRST INCIDENT HAPPENED FEW WEEKS AGO. THE PATIENT STARTS TO PANIC, WHEN HE FOUND OUT THE LEAK WON'T STOP, HE IS CONCERN FOR HIS MEDICATION WITH NOT BE PROPERLY INFUSED AND GIVEN. AND STERILITY OF GIVING MEDICINES IS AT RISK. DELAY IN THERAPY:YES. NEED FOR MEDICAL INTERVENTION:NO. PATIENT INVOLVEMENT: YES. DEATH / SERIOUS INJURY: NO. HUMAN HARM: NO."

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: LEAKAGE OF UNKNOWN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172783 AP402-01 HCR - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE ADMINISTRATION SET FPA Q CORE MEDICAL LTD. 56-5G

    Patients

    Seq Age Sex Outcome Treatment
    1