BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21279558 · Received January 30, 2025

    Report

    Report Number
    1710034-2025-00101
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 17, 2025
    Report Date
    April 3, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED 7 PHOTOS OF A 20GA X 1.00IN. INSYTE AUTOGUARD BC UNIT FOR THE INVESTIGATION. THE PHOTOGRAPH UNDER IMAGE 1-4 DISPLAYS A PINK MATTER ON THE CATHETER. THIS MATTER IS NOT FOREIGN, BUT APPEARS TO BE A BROKEN TAB FROM THE ADAPTER. YOUR REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. IN MANUFACTURING, DURING SEATING OF THE BARREL, IMPROPER MACHINE SETUP MAY CAUSE DAMAGE TO THE ADAPTER TAB. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. IMAGE 6 DISPLAYS WHAT APPEARS TO BE CATHETER DAMAGE. IT APPEARS TO HAVE A BUMP OR A CUT NEAR THE CATHETER TIP. ONLY THE CATHETER IS PROVIDED SO IT IS UNCLEAR IF THIS DAMAGE WAS CAUSED BY THE NEEDLE OR SOMETHING ELSE. WITHOUT THE PHYSICAL SAMPLES, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO PROVIDED PHOTOS DISPLAY ANY INDICATION OF FLASHBACK ISSUES THEREFORE WE WERE UNABLE TO CONFIRM YOUR REPORT FOR THIS. 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 AUTO G BC FOREING MATTER- PLASTIC ON CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE ATTACHED PHOTOS OF SOME DEFECTIVE IVS WE HAVE FOUND WITHIN THE LAST MONTH. THESE WERE ALL STRAIGHT OUT OF THE PACKAGE AND FOUND TO BE UNACCEPTABLE FOR PATIENT USE. I WORK IN DAY SURGERY, MY UNIT STARTS MANY IVS ON MANY TYPES OF PATIENTS. WE HAVE NOTICED THAT WE HAVE AN INCREASE IN BLOWN AND UNSUCCESSFUL IV ATTEMPTS. AFTER LOOKING CAREFULLY AT THE DISTAL ENDS OF THE CATHETERS, WE ARE SEEING EXTRA PLASTIC AT THE ENDS, PIECES OF THE HUB THAT ARE ATTACHED TO THE CATHETER, BENT CATHETERS, ETC.. THIS IS A POTENTIALLY HAZARDOUS PATIENT SAFETY PROBLEM. OUR NURSES AND MEDIC HAVE ALSO COMPLAINED THAT THE INSTAFLASH TECHNOLOGY IS NOT FUNCTIONING AS WELL AS THE EXACT SAME CATHETERS WE HAVE USED IN THE PAST.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504062 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162511 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown