BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20569245 · Received October 30, 2024

    Report

    Report Number
    1710034-2024-01234
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814442
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE B FOR ADDITIONAL INFORMATION RECEIVED. F CODE UPDATED.

    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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381444 AND LOT NUMBER 4141832. 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

    (B)(6) 2024. A CONTAMINATED NEEDLE STICK HAS BEEN REPORTED. WERE THERE ANY DIAGNOSTICS PERFORMED AS A RESULT OF THE CONTAMINATED NEEDLE STICK? YES. IF YES, WHAT DIAGNOSTICS WERE PERFORMED? RAPID HIV AND HEPATITIS. WAS ANY MEDICAL INTERVENTION REQUIRED? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT COMPLETELY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COLLEAGUE NOTICED THE END OF THE IV DEVICE WAS ¿CRUSHED¿ WHICH CAUSED THE NEEDLE TO NOT FULLY RETRACT INTO THE DEVICE WHEN THE PUSH BUTTON WAS ACTIVATED. THIS CAUSE A PART OF THE NEEDLE TIP TO STILL BE VISIBLE AT THE TOP OF THE DEVICE. (B)(6) 2024 COLLEAGUE WAS STUCK BY DIRTY NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959063 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4141832 00382903814442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown