BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL TAMPER EVIDENT CAP

    MDR report key: 14336295 · Received May 9, 2022

    Report

    Report Number
    14336295
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INNER WHITE CAPS BREAK OFF IN THE SYRINGE TIPS WE HAVE UTILIZED THEM FOR, BLOCKING DRUG FROM LEAVING THE 1ML SYRINGE. THIS BATCH WERE PARTICULARLY HIGH IN FAILURE RATE AND BREAKAGE. SEPARATELY, THESE DO NOT WORK WITH 1ML ORAL SYRINGES AND HAVE BEEN A KNOWN PROBLEM, BUT THE PACKAGING DOES NOT INDICATE IT WILL FAIL WITH ANY SIZE SYRINGE. THE WHITE PART OF THE TAMPER EVIDENT CAP BREAKS OFF IN THE TIP OF THE ORAL SYRINGE, AND THEREFORE THE SYRINGE IS CLOGGED, AND MEDICATION CANNOT BE ADMINISTERED, ALSO RUNNING THE RISK OF PLASTIC FRAGMENTS BEING INGESTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460089 ORAL TAMPER EVIDENT CAP DISPENSER, LIQUID MEDICATION KYX BAXTER HEALTHCARE CORPORATION H93852300 32165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown