BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD BC 20GA X1.16 IN

    MDR report key: 23256640 · Received October 9, 2025

    Report

    Report Number
    MW5177127
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S: PT HERE FOR SURGERY. HAVING PIV PLACED BY HEATH TECH. WHILE PLACING THE PIV, SHE HAD GREAT BLOOD RETURN. WHILE SLIDING THE CATHETER OFF OF THE NEEDLE, THE NEEDLE POKED THROUGH THE CATHETER. SHE THEN REMOVED BOTH THE CATHETER AND THE NEEDLE. B: NONE A: CATHETER NOTED TO BE INTACT BELOW THE LEVEL OF THE HOLE. R: IS THERE OTHER INFORMATION OR HISTORY OF CATHETERS HAVING ISSUES? CURRENT LOT# 5135741 WAS NOT PREVIOUSLY IDENTIFIED BY PREVIOUS PSR SUBMISSIONS OR THE FDA RECALL FROM 05/21/2025 PREVIOUS LOT #S IDENTIFIED AT THE FACILITY: 5045781, 3005948, 4193407 (NOT RECALLED) PREVIOUS LOT NUMBER FROM FDA RECALL: 4116814.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301735 BD INSYTE AUTOGUARD BC 20GA X1.16 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 5135741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention