BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 20418761 · Received October 10, 2024

    Report

    Report Number
    1710034-2024-01129
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815234
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: INVESTIGATION CODES POPULATED.

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 381523 AND LOT NUMBER 4123605. 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.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED DIFFICULT TO CONNECT T CONNECTOR TO HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLACED IV CATHETER BD INSYTE 22G AUTOGARD WINGED 1 IN. UNABLE TO CONNECT T-CONNECTOR EASILY, ATTEMPTED BY THIS RN AND LEXI A RN. EVENTUALLY AFTER 3 ATTEMPTS ABLE TO PLACE T-CONNECTOR BUT TOOK A PROLONGED AMOUNT OF TIME TO ATTACH. IT SOUNDS LIKE TWO OTHER NURSES HAD SIMILAR EXPERIENCES THE DAY PRIOR BUT DIDN¿T KEEP THE PACKAGE OR FILE INCIDENT. 23 SEP ¿ ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO ¿ HOW MANY EVENTS OCCURRED ONE CONFIRMED, TOTAL OF THREE SUSPECTED BUT THERE ARE NO DETAILS FOR THE OTHER TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189720 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123605 00382903815234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown