BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER

    MDR report key: 15470806 · Received September 22, 2022

    Report

    Report Number
    MW5112239
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    September 18, 2022
    Report Date
    September 21, 2022
    Manufacturer
    AZER SCIENTIFIC, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE AZOR ADAPTORS BECAME DETACHED WHILE PERFORMING A PHLEBOTOMY PROCEDURE. THIS IS OCCURRED WHILE USING THE BUTTERFLY NEEDLE. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077114 VACUTAINER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA AZER SCIENTIFIC, INC. 220504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown