BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 18749474 · Received February 21, 2024

    Report

    Report Number
    1710034-2024-00119
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    November 16, 2023
    Report Date
    March 20, 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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 DECEMBER OF 2023. MEDWATCH REPORT IS (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 3192172. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC BLU 22GA X 1.0IN CATHETER SHEARED. THE FOLLOWING INFORMATION WAS PROVIDED VIA MEDWATCH: REGISTERED NURSE (RN) STARTED A 22-GAUGE X 1 INCH IN THE LEFT ACROMIOCLAVICULAR JOINT. BLOOD RETURN NOTED. I TRIED TO ADVANCE CATHETER AND MET RESISTANCE. I NOTED THAT THERE WAS A "BUBBLE" WHERE THE CATHETER WAS UNDER THE SKIN. I PULLED THE NEEDLE WITH CATHETER OUT AND APPLIED PRESSURE. THE CATHETER WAS INTACT BUT SHEARED FROM NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602930 BD INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192172 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female