BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC 20G IV CATHETER

    MDR report key: 17650419 · Received August 29, 2023

    Report

    Report Number
    MW5145046
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 25, 2023
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BD INSYTE AUTOGUARD BC 20G IV CATHETERS ARE NOT WORKING PROPERLY. SAFETY BUTTON IS NOT ENGAGING WHEN DEPRESSED. NOTED AT 2 SEPARATE FACILITIES TODAY, PWH AND GRMH IN BOTH PREOP DEPARTMENTS. SAME LOT #3166524, AND REF# 382533, AFFECTED IVS REMOVED FROM CIRCULATION AND WORKING WITH MATERIALS TO GET NEW CATHETERS. REFERENCE REPORT: MW5145045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438940 BD INSYTE AUTOGUARD BC 20G IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD 3166524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other