BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 12173960 · Received July 15, 2021

    Report

    Report Number
    1043582-2021-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 15, 2021
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KPE
    UDI-DI
    50748426002080
    PMA / PMN Number
    K811233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING DIFFICULTY INSERTING THE 2000S SPIKES INTO BAGS OF HEPARIN 2000 UNITS IN SALINE 100 ML. IT WAS REQUIRING FORCE TO INSERT THE DECANTER INTO THE PORT ON THE SALINE BAGS AND THEY WERE USING A TWISTING MOTION THAT WAS CAUSING PLASTIC SHAVINGS TO RELEASE FROM THE BAG PORT THAT COULD POTENTIALLY FALL INTO THE SALINE SOLUTION. NO ADVERSE PATIENT REACTIONS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069674 MICROTEK MEDICAL INC. VIAL DECANTER KPE MICROTEK MEDICAL INC. 2000S 210113 50748426002080

    Patients

    Seq Age Sex Outcome Treatment
    1