BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20583031 · Received October 31, 2024

    Report

    Report Number
    1710034-2024-01249
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    January 1, 1980
    Report Date
    November 13, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    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. AN ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 382633. LOT # 4123611 MNF DATE 2024-05-23 EXP DATE 2027-04-30.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A DUPLICATE RECORD OF (B)(4), AND THE EVENT WAS SUBMITTED UNDER MDR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY PUSH THE WHITE BUTTON ON THE CATHETER IT IS HAVING A SLOW DELAY ON RETRACTING. WHEN NORMALLY IT RETRACTS QUICKLY. WAS THERE AN INJURY: NO WAS THERE A DEATH: NO. PRODUCT NUMBER - 382633. LOT NUMBER - 4222721 AND 4123611.

    Description of Event or Problem · 0

    THIS COMPLAINT IS A DUPLICATE RECORD OF (B)(4), AND THE EVENT WAS SUBMITTED UNDER MDR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067355 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown