BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED LLC

    MDR report key: 10171202 · Received June 18, 2020

    Report

    Report Number
    3000204189-2020-00003
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 15, 2020
    Manufacturer
    WALKMED, LLC
    Product Code
    FPA
    UDI-DI
    00859695006053
    PMA / PMN Number
    K870524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTED "I FOUND ANOTHER PARTICLE, OF THE SAME SORT THAT I DESCRIBED IN DECEMBER, IN A PUMP BAG THAT I WAS CHECKING." (IN REFERENCE TO ADDITIONAL COMPLAINT REPORTED ON 3000204189-2020-00001) SHE ALSO REPORTED "OF COURSE, FLUOROURACIL DOES CRYSTALIZE, SO IT'S POSSIBLE IT COULD BE A DRUG PARTICLE, BUT I CHECK THE VIALS AND THE TECH DOUBLE CHECKS THEM FOR ANY CRYSTALLIZATION BEFORE MIXING AND WE DIDN'T SEE ANY AFTER DRUG HAD BEEN PUT IN. I DON'T THINK IT WOULD HAVE BEEN LIKELY TO SEE IT BEFORE MIXING, BECAUSE IT IS TINY AND WHITE TO TRANSLUCENT. I DON'T THINK IT'S A FLUOROURACIL CRYSTAL THOUGH, BECAUSE THOSE SINK IN THE FLUOROURACIL SOLUTION AND THIS PARTICLE FLOATS." BAG WAS DISPOSED OF AFTER IDENTIFYING THE PARTICULATE. ADDITIONAL BAGS FROM THIS LOT WERE SENT TO WALKMED FOR REVIEW AND NO ADDITIONAL PARTICULATE WAS IDENTIFYING DURING TESTING. NO INTERNAL NON-CONFORMING REPORTS OR ADDITIONAL CUSTOMER RELATED COMPLAINTS HAVE EVER BEEN IDENTIFIED FOR PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635112 WALKMED LLC RESERVOIR BAG FPA WALKMED, LLC 204821 21018511 00859695006053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other