BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21201269 · Received January 21, 2025

    Report

    Report Number
    1710034-2025-00039
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    November 21, 2024
    Report Date
    February 11, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382534 AND LOT NUMBER 4193407. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOG BC NEEDLE PIERCED THE CATHETER, AND DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS PLACING AN IV ON PATIENT, WHILE TRYING TO ADVANCE THE CATHETER THE NEEDLE PUNCTURED THE CATHETER AND THE WHITE RETRACT BUTTON WOULD NOT ENGAGE TO RETRACT THE NEEDLE. NEEDLE WAS REMOVED, CATHETER WAS PUNCTURED BUT INTACT. WHITE BUTTON WAS DEPRESSED BUT NEEDLE WAS STILL OUT. NO INJURIES OCCURRED TO PATIENT OR RN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548256 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4193407 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male