BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19764509 · Received July 17, 2024

    Report

    Report Number
    1710034-2024-00732
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 17, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES WERE AVAILABLE TO INVESTIGATE THE REPORTED CONDITION. OUR QUALITY ENGINEER TEAM COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 382533 AND LOT NUMBER 4093240. THE REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CAUSED THIS DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. WITHOUT A SAMPLE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. COMPLAINTS FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC PNK 20GA X 1.0IN CATHETER RELEASES PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TAB THAT IS PUSHED FOR ADVANCING SPINS. FOLLOW-UP: CUSTOMER RESPONSE ON JUN 27, 2024. ONE NURSE OBSERVED THAT THE CATHETER WAS NOT SECURED AT THE BASE OF THE NEEDLE AND THE FINGER TAB USED TO ADVANCE THE CATHETER SPUN BEFORE SHE WAS READY TO ADVANCE IT. PATIENTS HAD BRUISING AND/OR UNNECESSARY PAIN FROM HAVING MORE THAN ONE IV START.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040510 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4093240 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown