BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOINK

    MDR report key: 14346020 · Received May 10, 2022

    Report

    Report Number
    14346020
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 15, 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

    ENDOINK¿, A SINGLE-USE FLUID DESIGNED TO ENDOSCOPICALLY MARK LESIONS IN THE GASTROINTESTINAL TRACT, WOULD NOT ATTACHED TO THE CARR-LOCKE INJECTION NEEDLE. A NEW ENDOINK¿ NEEDLE WAS OBTAINED AND CASE CONTINUED WITOUTH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295980 ENDOINK MARKER, COLON NBG MICRO-TECH (NAN JING) CO., LTD. ENK10 M210726252

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA Unknown