BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20571848 · Received October 30, 2024

    Report

    Report Number
    1710034-2024-01242
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 9, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 24GA X 0.75IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 4162538. THE NEEDLE WAS RECEIVED EXTENDED FROM THE SAFETY SHIELD. THE SAFETY MECHANISM HAD BEEN ACTIVATED, BUT THE NEEDLE HUB HAD NOT RETRACTED. THE NEEDLE FULLY RETRACTED WHEN A SLIGHT FORCE WAS APPLIED TO THE NEEDLE HUB. A MICROSCOPIC EXAMINATION OF THE NEEDLE REVEALED NO DAMAGE OR DEFECTS THAT WOULD PREVENT THE NEEDLE FROM RETRACTING. ALTHOUGH YOUR REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WOULD NOT RETRACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886371 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162538 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown