BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC PNK 20GA X 1.0IN

    MDR report key: 18906048 · Received March 14, 2024

    Report

    Report Number
    1710034-2024-00185
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    September 14, 2023
    Report Date
    March 21, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    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 NOVEMBER OF 2023. MEDWATCH REPORT IS (B)(4). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 382533 AND LOT NUMBER 3142661. 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 PNK 20GA X 1.0IN CATHETER CONTAINED A BREAK. THE FOLLOWING INFORMATION WAS PROVIDED VIA MEDWATCH: THE IV NEEDLE WAS TAKEN OUT OF THE PACKAGING AND THE RESERVOIR WAS SLIGHTLY MOVED TO LOOSEN UP. REGISTERED NURSE (RN) NOTICED THAT THE TIP OF THE CATHETER WAS ALMOST BREAKING OFF AND HANGING BY A THREAD. RN DISPOSED OF DAMAGED CATHETER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969837 BD INSYTE AUTOG BC PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3142661 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown