BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 16603390 · Received March 23, 2023

    Report

    Report Number
    3005798905-2023-03105
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 23, 2023
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    PMA / PMN Number
    K130212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 55773 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 55773. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE COLORADO DEPARTMENT OF PUBLIC HEALTH REPORTED THAT WHILE USING LUER LOCK SYRINGE, ITEM NUMBER 802015 LOT 55773 WITH PFIZER COVID SINGLE DOSE VACCINE VIAL THE SYRINGE IS DRAWING LESS THAN 0.3ML. THE REPORTER OF THE EVENT HAS ALSO RELAYED THE SAME INFORMATION TO A REPRESENTATIVE AT PFIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835977 EASYTOUCH SAFETY SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD 55773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown