BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC PNK 20GA X 1.0IN

    MDR report key: 19920901 · Received August 6, 2024

    Report

    Report Number
    1710034-2024-00832
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 12, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. 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 SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 4110947. A LEAK TEST WAS PERFORMED WHERE NO LEAKS WERE DETECTED. A VISUAL INSPECTION WAS PERFORMED, BUT NO DAMAGES WERE DISCOVERED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    MATERIAL# 382533; BATCH# 4110947. IT WAS REPORTED BY CUSTOMER THAT LEAKING IDENTIFIED FROM CATHETER WHERE CATHETER MATERIAL MEETS PLASTIC CATHETER HUB. ADDITIONAL INFORMATION: NO PATIENT HARM WAS DONE. JUST LEAKING FROM BETWEEN THE PINK HUB AND THE WHITE CATHLON.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702523 INSYTE AUTOG BC PNK 20GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4110947 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown