BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE TRI-FUSE SET

    MDR report key: 7997140 · Received October 23, 2018

    Report

    Report Number
    9616066-2018-01979
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Report Date
    September 26, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403235955
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    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. CONCOMITANT DISPOSABLES: (2) BBRAUN CARESITE NFV; BBRAUN SMALLBORE EXTENSION SET; PRE-FILLED SYRINGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A GENERALIZED RECURRING PRODUCT CONCERN IN WHICH THE MALE LUER IS UNABLE TO BE DISCONNECTED AND BECOMES STUCK INSIDE THE VALVE OR THE FEMALE LUER OF THE MATING DEVICE THAT IT IS CONNECTED TO. THE NURSING STAFF HAVE RESORTED TO ATTEMPTING TO REMOVE THE TUBING SET FROM THE PATIENT WHILE USING HEMOSTATS ONLY TO HAVE THE MALE LUER BREAK OFF. THE CUSTOMER FURTHER STATES THAT THEY DO NOT USE ALCOHOL ON THE MALE LUER WHEN THEY CONNECT THE SETS TOGETHER. THE NURSE WILL PRIME THE SET WITH THE FLUID THAT WILL BE DELIVERED AND THEN CONNECT THE SYRINGE TO THE SET AND PRIME UNTIL THE FLUID EXITS AT THE MALE LUER WITH THE DUCT CAP STILL ATTACHED., THIS IS ALSO DONE FOR DEXTROSE AS WELL. BEFORE THE NURSE CONNECTS THE MALE LUER TO AN OPEN FEMALE LUER, THE NURSE WILL USE A PREFILLED SYRINGE TO PLACE SALINE INTO THE FEMALE LUER BEFORE CONNECTION TO ENSURE THAT AN AIR BUBBLE IS NOT INTRODUCED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835584 MINIBORE TRI-FUSE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION ME1021 10885403235955

    Patients

    Seq Age Sex Outcome Treatment
    1