BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP

    MDR report key: 8232393 · Received January 9, 2019

    Report

    Report Number
    3006575795-2019-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 3, 2019
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FPA
    UDI-DI
    00814371020600
    PMA / PMN Number
    K120685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAKING ISSUE WAS NOT CONFIRMED. THE SERVICE PROVIDER OF ZYNO MEDICAL PERFORMED THE TESTING ON THREE RETURNED DEVICES FROM THE SAME LOT AS THE AFFECTED DEVICE ON 04/17/2019. NO LEAKING WAS OBSERVED ON THE SAMPLES TESTED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3006575795-2019-00002).

    Additional Manufacturer Narrative · 1

    THE AFFECTED SET IS NOT YET RETURNED TO THE DISTRIBUTOR.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED A LEAKING ISSUE OF AN ADMINISTRATION SET TO ZYNO MEDICAL ON (B)(6) 2019. THE DISTRIBUTOR RECEIVED AN EMAIL FROM THE INITIAL REPORTER ON (B)(6) 2019, STATING THAT THE ADMINISTRATION SET TUBING WAS LEAKING FROM THE AIR VENT ON THE DRIP CHAMBER. THE MEDICATION BEING INFUSED WAS DOXORUBICIN. THERE WAS NO PATIENT INJURY AND NO PATIENT INFORMATION WAS PROVIDED TO ZYNO MEDICAL. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS AMSINO INTERNATIONAL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25314 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET FPA ZYNO MEDICAL LLC AA80075 123363KS 00814371020600

    Patients

    Seq Age Sex Outcome Treatment
    1