BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE 3ML RG MEDICATION

    MDR report key: 12728420 · Received October 29, 2021

    Report

    Report Number
    MW5105043
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 21, 2021
    Report Date
    October 21, 2021
    Product Code
    MRZ
    UDI-DI
    55555048723
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INBOUND; PT REPORTS DRAWING UP 2.8 ML OF TREPROSTINIL IN SYRINGE AND AFTER LOADING, FILLING TUBING AND STARTING INFUSION, THE PUMP DISPLAYS HER ONLY HAVING 1.5 ML LEFT, WHICH WILL NOT LAST HER 72 HOURS. HER SYRINGE ACTUALLY HAS 2.6 MLS IN IT BUT SINCE THE PUMP CANNOT READ THAT, IT WILL THINK IT IS EMPTY SOONER. ASSISTED PT WITH RELOADING THE SYRINGE AND NO CHANGE IN VOLUME. PRIOR TO DRAWING UP DRUG, PT LUBRICATES THE SYRINGE BY PUSHING AND PULLING THE PLUNGER, TWELVE TIMES. THE LOT NUMBER FOR SYRINGE IS 210408, EXP: 4/7/2026. NO FURTHER DETAILS PROVIDED. WHELE LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616931 CARTRIDGE 3ML RG MEDICATION ACCESSORIES, PUMP, INFUSION MRZ 210408 55555048723

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR