BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 7863713 · Received September 11, 2018

    Report

    Report Number
    7863713
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 30, 2018
    Report Date
    August 31, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE EVENTS WITH IV CATHETERS INCLUDING: DURING ATTEMPT TO OBTAIN PERIPHERAL IV ACCESS, NURSE WAS UNABLE TO ADVANCE THE CATHETER SO PULLED IT OUT AND THE NEEDLE WAS NOTED TO BE STICKING THROUGH THE BENT CATHETER. AFTER 2ND ATTEMPT, IV ACCESS WAS SUCCESSFULLY OBTAINED. (WHILE ACCESSING PATIENT FOR IV INJECTION, THE CATHETER PEELED AWAY FROM THE NEEDLE. THE 18 GAUGE JELCO ATTEMPTED TO PLACE AND NEEDLE SHEARED THE CATHETER IN TWO. THESE INVOLVED THE FOLLOWING: THE 22 G REF. (B)(4) - LOT#8134969, LOT # 8120663, & LOT # 8095877. THE 20 G REF. # (B)(4) - LOT#8134963. THE 24 G REF. # (B)(4) - LOT#7027892.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704764 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 381523 8134969

    Patients

    Seq Age Sex Outcome Treatment
    1