BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD IV CATHETER, 18G

    MDR report key: 19434983 · Received May 30, 2024

    Report

    Report Number
    MW5155635
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MANUFACTURER: BD PRODUCT: INSYTE AUTOGUARD SHIELDED IV CATHETER. MOUNTAIN HOME LOT NUMBERS: 3320957, 4059384, 4010709, 4004944. AFTER SUCCESSFULLY CANNULATING A PATIENTS VEIN AND RETRACTING THE NEEDLE, BLOOD SPLATTERS BACK ONTO PATIENTS AND STAFF. NO PATIENT HARM HAS OCCURRED. PACKAGING FROM DEVICES WERE PROVIDED TO MANUFACTURER REPRESENTATIVE FOR FURTHER EVALUATION. THE ISSUE WAS ESCALATED TO THE VA NATIONAL CENTER FOR PATIENT SAFETY AND THIS REPORT IS BEING COMPLETED BASED UPON GUIDANCE CONTAINED WITHIN THE VHA PATIENT SAFETY NOTICE N24-014 ADDENDUM PUBLISHED ON OCTOBER 4, 2023. REFERENCE REPORTS: MW5155632, MW5155633, MW5155634.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594853 INSYTE AUTOGUARD IV CATHETER, 18G CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3320957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown