BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N AUTOGUARD

    MDR report key: 20605844 · Received November 4, 2024

    Report

    Report Number
    1710034-2024-01258
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814114
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF A DAMAGED CATHETER WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THREE 24G INSYTE AUTOGUARD DEVICES WERE PROVIDED FOR INVESTIGATION FROM LOT NUMBER 4072326. A MICROSCOPIC EXAMINATION OF THE CATHETERS REVEALED THAT THE TIPS WERE ACCEPTABLE ACCORDING TO THE VISUAL STANDARD. A V-SHAPED BREACH WAS OBSERVED IN ONE CATHETER TUBING NEAR THE TIP, WHICH WAS CONSISTENT WITH NEEDLE PUNCTURE DAMAGE. AS THE DEVICE HAD BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD NEEDLE TIP SHEARED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A PRODUCT COMPLAINT ON (B)(6) 2024 FROM OUR NURSERY ¿IV CATHETER NOTED TO BE SHEARING AT THE TIP WHEN VISUALLY INSPECTING IT PRIOR TO INSERTION. BD INSYTE 24G X0.56IN. LOT#: 4101326.¿ THERE WAS NO PATIENT HARM AND WE SHOULD HAVE THE CATHETER (1 EA) TO RETURN FOR A SAMPLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599670 BD INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4101326 00382903814114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown