BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COST CONTAINMENT, AMBER, 3 ML

    MDR report key: 19467624 · Received June 5, 2024

    Report

    Report Number
    1416980-2024-02737
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Report Date
    July 12, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KYX
    UDI-DI
    00085412479385
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER NAME: ECM - RR DONNELLEY SUPPLY CHAIN SOLUTION - SP017692. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTIONS WERE MADE TO D4. ADDITIONAL INFORMATION WAS ADDED TO G4, H6, AND H11: H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT MANY SEGMENTS OF THE SYRINGE VOLUME LINE MARKINGS WERE NOT IMPRINTED AND MISSING ON THE SYRINGE BODY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXACTAMED 3ML ORAL SYRINGE WAS MISSING THE GRADUATION LINES THAT INDICATE VOLUME. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824510 COST CONTAINMENT, AMBER, 3 ML DISPENSER, LIQUID MEDICATION KYX BAXTER HEALTHCARE CORPORATION H93884203 B302T346P 00085412479385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown