BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20615703 · Received November 5, 2024

    Report

    Report Number
    1710034-2024-01272
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381412 AND LOT NUMBER 4110694. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR FACILITY HAS BEEN NOTICING SOME CONCERNS WHILE UTILIZING THE INSYTE AUTOGUARD 24G X 0.75IN. IT HAS BEEN REPORTED FROM NURSING STAFF THAT ONCE THEY HAVE DETERMINED THEY ARE IN THE VEIN, AS THEY ARE REMOVING THE NEEDLE FROM THE CATHETER, THE NEEDLE IS POKING THROUGH THE CATHETER, THUS BLOWING THE VEIN.ONCE THE CATHETER IS REMOVED FROM THE PATIENT, THERE IS AN OBVIOUS HOLE NOTED IN THE CATHETER. ONCE THIS WAS NOTICED, STAFF WERE "TESTING" THE INSYTE AND PRIOR TO INSERTING THE NEEDLE INTO THE PATIENT, THEY WERE SLIDING THE CATHETER UP AND DOWN ON THE NEEDLE AND THE NEEDLE WAS POKING THROUGH THE CATHETER THIS TIME AS WELL. THIS HAS CAUSED MULTIPLE IV POKES FOR OUR PREMATURE INFANTS AND CAUSING US TO UTILIZE MANY INSYTES. SOME OF THE LOT NUMBERS THAT WERE NOTED DURING THESE CONCERNS WERE AS FOLLOWS: 4110694, 4070998, AND 4129761. I AM WONDERING IF YOU HAVE HAD OTHER COMPLAINTS OR CONCERNS OF THIS SIMILAR PROBLEM OCCURRING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998205 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4110694 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown