BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC PNK 20GA X 1.16IN

    MDR report key: 20356165 · Received October 2, 2024

    Report

    Report Number
    1710034-2024-01090
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 13, 2024
    Report Date
    January 13, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WHICH DISPLAYED THE IMPLICATED 20G INSYTE AUTOGUARD BC IV CATHETER. YOUR REPORT OF PLASTIC AT THE CATHETER TIP WAS CONFIRMED FROM THE PHOTOGRAPHS THAT WERE PROVIDED FOR INVESTIGATION; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PHOTOS. THE CATHETER TIP APPEARED TO BE EITHER DAMAGED OR HAVE UNINTENDED MATERIAL AT THE TIP. THE EXTENT OF THE DAMAGE AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DISCERNED FROM THE PHOTOGRAPHS. AS THE DEVICE HAS BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. THE OBSERVABLE FEATURES ON THE SUBMITTED PHOTOGRAPHS DID NOT CONTAIN ENOUGH INFORMATION TO IDENTIFY A SPECIFIC ROOT CAUSE FOR YOUR REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL #: 382534; BATCH#: 4102969. IT WAS REPORTED BY CUSTOMER THAT THERE ARE MICROPLASTIC PARTICULATES ON THE TIP. HAD A SPARE THAT HAD NO CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091649 INSYTE AUTOG BC PNK 20GA X 1.16IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4102969 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown