BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOINK

    MDR report key: 14999540 · Received July 13, 2022

    Report

    Report Number
    14999540
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    April 9, 2022
    Report Date
    June 22, 2022
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    NBG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LUER TIP OF THE ENDOINKTM ENDOSCOPIC MARKER LEAKED WHEN ATTACHED TO SYRINGE. A NEW SETUP WAS OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. THE ORIGINAL DEVICE AND PACKAGING WERE DISCARDED AFTER NUMBERS ATTACHED, EDUCATION PROVIDED TO SAVE ITEMS EVEN IF MESSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714069 ENDOINK ENDOSCOPIC MARKER NBG MICRO-TECH (NAN JING) CO., LTD. M210719252

    Patients

    Seq Age Sex Outcome Treatment
    1 9855 DA Unknown