BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20750229 · Received November 21, 2024

    Report

    Report Number
    1710034-2024-01384
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 3, 2025
    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
    NH, 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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 4123607. 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

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: RETRACTIONS ISSUES HAVE OCCURRED, THE BUTTON WAS NOT FUNCTIONING CORRECTLY, OCCURRENCES HAPPENED WHERE THERE WAS PREMATURE RETRACTION. THEN CLINICIANS TESTED SEVERAL OF THE DEVICES NOT ON ANY PATIENTS AND CAME ACROSS THE NON-RETRACTION ISSUE ALL OCCURRENCES HAPPENED ON 29OCT2024 PT/CLINICIAN HARM: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256177 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123607 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown