BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20664792 · Received November 12, 2024

    Report

    Report Number
    1710034-2024-01309
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 4102965. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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 LEAKED AT THE HUB/IV TUBING JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY WE HAD IN INCIDENT WITH ONE OF THE BD INSYTE AUTOGUARD 22 GAUGE IV CATHETERS. MY ASU RN INSERTED THE CATHETER, WAS ABLE TO OBTAIN A FLASH, SO TOOK THE NEEDLE OUT AND WHEN SHE TRIED TO HOOK UP THE IVF, IT WAS LEAKING AT THE HUB. SHE UNSCREWED THE IVF FROM THE HUB OF THE CATHETER, AND TRIED TO SCREW IN AGAIN, AND IT STILL LEAKED. ULTIMATELY, SHE HAD TO REMOVE THE CATHETER COMPLETELY AND INSERT ANOTHER ONE, AT ANOTHER SITE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059611 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4102965 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown