BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20344987 · Received October 1, 2024

    Report

    Report Number
    1710034-2024-01079
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    July 22, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6). THIS MDR IS THE RESULT OF AN INVESTIGATION FINDING: THE COMPLAINT THAT THE CATHETER WAS STICKING WHEN ADVANCED WAS CONFIRMED FROM CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED ON THE REPRESENTATIVE 24G INSYTE AUTOGUARD DEVICES THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #4143183. THE AFFECTED UNIT WAS NOT PROVIDED FOR INVESTIGATION. DEFORMATION WAS OBSERVED WITHIN ONE CATHETER ADAPTER, WHICH PUSHED MATERIAL FROM THE OPENING OF THE CATHETER ADAPTER INTO THE LUER TAPER. THE EXTRA MATERIAL APPEARED TO CAUSE RESISTANCE BETWEEN THE CATHETER ADAPTER AND THE NEEDLE HUB WHEN ATTEMPTING TO ADVANCE THE IV CATHETER OFF THE NEEDLE HUB. AS THE SAMPLE WAS RECEIVED IN SEALED PACKAGING, THE DAMAGE LIKELY OCCURRED DURING MANUFACTURING. MISALIGNMENT DURING ASSEMBLY MAY HAVE BEEN A CONTRIBUTING FACTOR. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT AND ADDITIONAL COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FROM THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC ADAPTER/CONNECTOR IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER SHEATH ¿STICKS¿ WHEN WE TRY TO ADVANCE IT. I¿VE TRIED SEVERAL NEEDLES AND THE PROBLEM IS ABLE TO BE REPLICATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40129 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4143183 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown