BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 21756070 · Received April 2, 2025

    Report

    Report Number
    1710034-2025-00510
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826346
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382634 AND LOT NUMBER 4242432. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL ENCOUNTERING NEEDLE STICK ISSUE WITH THIS SPECIFIC ORDER. DEPT. REQUESTING RETURN 6 CA FOR CREDIT. CUSTOMER RESPONSE ON 27-MAR-2025. XXX, XXX, WE HAVE RESPONDED PROVIDED DETAILS AND THE ONCE AGAIN THE REASON WE RETURNED THE 6 CASES WAS THERE WAS AN INCIDENT THAT THE NEEDLED DID NOT RETRACK WITHOUT INCIDENT. I INCLUDED XXX FROM ED AS THE "INCIDENT" OCCURRED IN THAT DEPARTMENT. I AGREE WITH XXX. THE MOST RECENT INCIDENT DID NOT RESULT IN A NEEDLE STICK INJURY. THE NEEDLE DID NOT RETRACT AS IT SHOULD HAVE AFTER THE BUTTON ON THE HANDLE WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372639 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242432 00382903826346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown