BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 18782220 · Received February 26, 2024

    Report

    Report Number
    1710034-2024-00137
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    October 6, 2023
    Report Date
    April 1, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. E4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA OCTOBER 2023. MEDWATCH REPORT IS 2300380000-2023-8048. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE AUTOGUARD PNK 20GA X 1.16IN DID NOT RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED VIA MEDWATCH "INTRAVENOUS (IV) CATHETER WOULD NOT RETRACT NEEDLE WHEN BUTTON WAS PUSHED. IT WAS A 20 GA X 1.16 IN INSYTE AUTOGUARD IV CATHETER. LOT # 3192264".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296764 BD INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192264 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female