BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 9857864 · Received March 19, 2020

    Report

    Report Number
    9616066-2020-00828
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 6, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203012393
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE LCI MAIN THAT THE 0.2 MICRON LOW PROTEIN BINDING FILTER CRACKED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OF THE 0.2 MICRON LOW PROTEIN BINDING FILTERS ARE CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319065 EXTENSION SET SET,ADMINISRATION,INTRAVASCULAR FPA CAREFUSION 20028E 19095990 07613203012393

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING,8100,8015, TD UNK| TD 02/05/2020