BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21471847 · Received February 26, 2025

    Report

    Report Number
    1710034-2025-00319
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 12, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOGRAPHS OR PHYSICAL SAMPLES ILLUSTRATING THE REPORTED ISSUE WERE ACCESSIBLE FOR EXAMINATION. OUR QUALITY ENGINEERING TEAM CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED MATERIAL NUMBER 382544 AND LOT NUMBERS 4312025 AND 4355980. THIS REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE LED TO THE DEFECT, AND ALL QUALITY TESTS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. GIVEN THE INFORMATION AT HAND, WE WERE UNABLE TO DETERMINE A SPECIFIC CAUSE FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. AN ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 382544. LOT # 4312025 MNF DATE 01.10.2024 EXP DATE (B)(6) 2027.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE ONLY PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING THAT DEVICE IS NOT FULLY RETRACTING AND LEAVING AN EXPOSED NEEDLE THAT IS DANGEROUS TO THE CLINICIAN AND PATIENT. DATES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250268 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4355980 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown