BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED

    MDR report key: 14498474 · Received May 25, 2022

    Report

    Report Number
    3000204189-2022-00001
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 25, 2022
    Manufacturer
    WALKMED, LLC
    Product Code
    FPA
    PMA / PMN Number
    K870524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CLINIC REPORTED "WHEN FINISHED COMPOUNDING THE MEDICATION IN THE IPR 150 THERE IS SOME SORT OF PARTICULATE FLOATING INSIDE THE BAG." PICTURES WERE PROVIDED HOWEVER BAG WAS NOT RETURNED. THERE WAS NO PATIENT IMPACT SINCE THE PARTICULATE WAS IDENTIFIED IN THE BAG DURING SETUP. FROM ADDITIONAL COMMUNICATION WITH THE CLINIC, THEY IDENTIFIED THE PHARMACY TECHNICIANS MIGHT BE INTRODUCING THE PARTICULATE IN THEIR PROCESS. AS PART OF OUR INVESTIGATION, WALKMED VISITED THE CLINIC. WALKMED PERSONNEL WITNESSED A SINGLE TECHNICIAN WAS RESPONSIBLE FOR INTRODUCING THE PARTICULATE INTO THE RESERVOIR BAG DURING THE DRUG COMPOUNDING PROCESS. THE CLINIC PERSONNEL AGREED THAT THEY WERE RESPONSIBLE. WALKMED ADVISED RETRAINING OF THE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259890 WALKMED RESERVOIR BAG FPA WALKMED, LLC IPR 150 21021505 OR 21021507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other