BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER ADAPTER, 20GX3/4 1BX/100EA

    MDR report key: 20629627 · Received November 5, 2024

    Report

    Report Number
    MW5162253
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Manufacturer
    UNK
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY FRESENIUS MEDICAL CARE NORTH AMERICA. IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY CLINIC MANAGER ANDREA HUGHES THAT: LUER ADAPTER BREAKING OFF IN PATIENT CATHETER HUB, THIS WAS A SECOND OCCURRENCE FOR THIS PATIENT IN ONE WEEK AND RESETED IN HAVING TO CATHETER EXCHANGE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875750 LUER ADAPTER, 20GX3/4 1BX/100EA TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA UNK 22K09A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown