BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19971702 · Received August 13, 2024

    Report

    Report Number
    1710034-2024-00864
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 9, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: THE COMPLAINT OF A DAMAGED CATHETER ADAPTER AND A LEAK COULD NOT BE CONFIRMED FROM THE UNUSED REPRESENTATIVE 22G INSYTE AUTOGUARD DEVICES THAT WERE RECEIVED FROM LOT #4082073. A VISUAL EXAMINATION AND FUNCTIONAL TEST REVEALED NO DAMAGE OR DEFECTS WITH THE RETURNED SAMPLES. THE AFFECTED UNITS WERE NOT RETURNED FOR INVESTIGATION. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC INCOMPLETE HUB LEAKS AT CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AMBULATORY SURGERY AT XX HOSPITAL HAD ISSUE LAST WEEK WITH IV CATHETERS LEAKING WHERE THE BLUE HUB CONNECTS TO THE EXTENSION TUBING. IT APPEARS THAT PART OF THE BLUE HUB WAS MISSING. STARTED A #22 BD INSTYLE AUTOGAURD BC IV ON THIS PATIENT. GOOD BLOOD RETURN. FLUSHED WITH 10CC SALINE. DRESSED. 10 MINUTES LATER PATIENT CALLED TO SAY IT WAS LEAKING. PIECE OF BLUE HUB APPEARS TO BE MISSING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640165 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4082073 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown