BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED

    MDR report key: 1830200 · Received September 3, 2010

    Report

    Report Number
    1830200
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO ANGIOCATHETERS APPEARED TO SHRED UPON INSERTION. CATHETERS WERE REPLACED BY ANGIOCATHS FROM DIFFERENT LOT NUMBER. PATIENTS WERE NOT INJURED. ENTIRE LOT NUMBER REMOVED FROM SUPPLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER FOZ BD MEDICAL * 0106746

    Patients

    Seq Age Sex Outcome Treatment
    1 *