BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICK TIP INJECTION NEEDLE

    MDR report key: 10777919 · Received November 2, 2020

    Report

    Report Number
    MW5097617
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 14, 2020
    Report Date
    October 30, 2020
    Manufacturer
    MEDI-GLOBE GMBH
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CLICK-TIP INJECTION NEEDLE WAS USED TO CONTROL BLEEDING AFTER SPHINCTEROTOMY WAS PERFORMED DURING ERCP. AT FIRST 1/2CC EPINEPHRINE WAS INJECTED THRU CLICK-TIP THEN NEEDLE WAS WITHDRAWN BACK INTO SHEATH. SECOND TIME NEEDLE WAS DEPLOYED IT CAME OUT SIDE OF SHEATH. CLICK-TIP WAS REMOVED FROM SCOPE AND A DIFFERENT CLICK TIP HAD TO BE USED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238185 CLICK TIP INJECTION NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK MEDI-GLOBE GMBH G1826768

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention