BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20526583 · Received October 24, 2024

    Report

    Report Number
    1710034-2024-01193
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 22, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    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. E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 22GX1.00IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 4141834. A GROSS VISUAL INSPECTION SHOWS THAT ONLY THE CATHETER ASSEMBLY WAS RETURNED AND THERE IS NO APPARENT PHYSICAL DAMAGE. A V-SHAPED BREACH WAS OBSERVED IN THE TUBING, WHICH WAS CONSISTENT WITH NEEDLE PUNCTURE DAMAGE. AS THE DEVICE HAS BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. SITUATION: ISSUE: THIS PATIENT REQUIRED IV PLACEMENT FOR A PROCEDURE TO BE DONE IN THE EMERGENCY DEPARTMENT, UPON PLACING THE IV IN THE RIGHT AC IT HAD UNUSUAL BLEEDING AROUND THE INSERTION SITE, AND I WAS ALSO ABLE TO VISUALIZE THE NEEDLE OUTSIDE OF THE CATHETER. EVENT DATE: 9/22/2024 WAS THERE INJURY? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790046 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4141834 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown