BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC 20 GA X 1.16 IN

    MDR report key: 18142102 · Received November 14, 2023

    Report

    Report Number
    MW5148149
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 21, 2023
    Report Date
    October 23, 2023
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD INSTE AUTOGUARD BC 20 GA X 1.16 IN IV CATHETER/NEEDLE. LOT: 3142368, MANUFACTURE DATE: 2023-05-01, EXPIRATION: 2026-04-30. REMOVED PROTECTIVE CAP FROM NEEDLE, METAL IV NEEDLE COMING FROM SIDE OF PLASTIC IV CATHETER WITH CATHETER BENT TO THE SIDE. ITEM NOTED USED, METAL NEEDLE PLACED IN SHARPS CONTAINER. REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234530 BD INSYTE AUTOGUARD BC 20 GA X 1.16 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON AND COMPANY 3142368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown