BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC PNK 20GA X 1.16IN

    MDR report key: 20108854 · Received August 30, 2024

    Report

    Report Number
    1710034-2024-00967
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382534 AND LOT NUMBER 4152057. 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

    MATERIAL #: 382534. BATCH #: 4152057. IT WAS REPORTED THAT THE BD INSYTE AUTOG BC PNK 20GA X 1.16IN LEAKED BEYOND THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER VERBATIM: UPON DEPLOYING SAFETY NEEDLE RETRACTOR FROM IV CATHETER, THE SAFETY VALVE IS FAILING. THERE SHOULD NOT BE ANY BLOOD FLOW FROM THE CATHETER AND I HAVE EXPERIENCE BLOOD SPLATTER FROM THE CATHETER HUB. THIS HAS HAPPENED THREE TIMES TO ME THIS WEEK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910815 BD INSYTE AUTOG BC PNK 20GA X 1.16IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown