BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7683744 · Received July 12, 2018

    Report

    Report Number
    9616066-2018-01015
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 19, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233999
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: NON-BD BLOOD BAG O RH POSITIVE RED BLOOD CELLS CULOT GLOBULAIRE, EXP 29JUN2018; NON-BD (BAXTER) 250ML INFUSION BAG 0.9% SODIUM CHLORIDE INJECTION USP, LOT W8E18C1, EXP AUG19; BD POSIFLUSH SP SYRINGE 0.9% SODIUM CHLORIDE (0.9% NACL) 10ML REF (B)(4), LOT 8082725, EXP 2021-03. THE CUSTOMER¿S REPORT OF A LEAK AT THE CONNECTION OF THE MALE LUER TO THE NEEDLELESS CONNECTOR WAS CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED AND LEAKING WAS OBSERVED FROM THE ENGAGEMENT BETWEEN THE PRIMARY SET'S DISTAL LUER END AND THE MAXZERO VALVE. FURTHER INSPECTION OF THE VALVE'S TOP COMPONENT SHOWED A MICROCHANNEL/SCRATCH WITHIN THE INTERIOR DIAMETER. THE ROOT CAUSE OF THE LEAK WAS A MICROCHANNEL/SCRATCH WITHIN THE INTERIOR DIAMETER OF THE MAXZERO VALVE, CAUSED BY A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT TOWARD THE END OF THE RBC TRANSFUSION, BLOOD LEAKED AT THE CONNECTION OF THE MALE LUER TO THE NEEDLELESS CONNECTOR ON THE PATIENT'S PICC LINE. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SET WAS LEAKING AT THE MALE LUER DURING AN INFUSION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522965 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403233999

    Patients

    Seq Age Sex Outcome Treatment
    1 10015414, PICC LINE, THERAPY DATE (B)(6) 2018