BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC GLOBAL

    MDR report key: 19310659 · Received May 14, 2024

    Report

    Report Number
    1710034-2024-00435
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 17, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED THE SAFETY SHIELD FROM THE IMPLICATED INSYTE AUTOGUARD BC PRO REFERENCING #381044, LOT NUMBER 4012529. THE PHOTO SHOWED A PARTIALLY SHIELDED NEEDLE FROM AN INSYTE AUTOGUARD DEVICE. THE NEEDLE EXHIBITED EVIDENCE OF USE. THE TIP OF THE NEEDLE REMAINED EXTENDED FROM THE OPENING OF THE SHIELD. THE NEEDLE HUB WAS NOT FULLY SEATED AT THE BOTTOM OF THE BARREL. IT COULD NOT BE DETERMINED FROM THE PHOTO WHAT PREVENTED THE NEEDLE FROM FULLY RETRACTING. ALTHOUGH YOUR REPORTED ISSUE WAS CONFIRMED, THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY A DEFINITE ROOT CAUSE. WITHOUT THE PHYSICAL SAMPLE, FURTHER INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CORRECTION OF E CODE: CHANGED E-CODE FROM E2401 INSUFFICIENT INFORMATION TO E2010 NEEDLE STICK/PUNCTURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: SAMPLE PHOTO PROVIDED SHOWED THE PRODUCT BATCH NUMBER OF "4012529."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL INCOMPLETE NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE FAILED TO CLICK INTO THE SAFETY CONTAINER, WHICH CAUSED A NEEDLE STICK INJURY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102512 BD INSYTE AUTOG BC GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4012529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other