BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20825129 · Received December 2, 2024

    Report

    Report Number
    1710034-2024-01412
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 3, 2024
    Report Date
    November 13, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER: 382544 AND LOT NUMBER: 4222728. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC BLOOD CONTROL FEATURE DID NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CCT IN TO PERFORM IV INSERTION. UPON SUCCESSFUL IV INSERTION AND NEEDLE RETRACTION, BLOOD STARTED POURING FROM THE HUB OF THE NEWLY PLACED IV. CCT WAS USING A SHIELDED 18G IV CATHETER WITH BLOOD CONTROL TECHNOLOGY: RADIOPAQUE. 13 NOV. 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. UPON SUCCESSFUL IV INSERTION AND NEEDLE RETRACTION, BLOOD STARTED POURING FROM THE HUB OF THE NEWLY PLACED IV. NO PATIENT HARM, NO INJURY, COMPLICATIONS WERE LISTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132421 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222728 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown