BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20072195 · Received August 26, 2024

    Report

    Report Number
    1710034-2024-00937
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 15, 2024
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SEE B DESCRIBE EVENT OR PROBLEM. PATIENT GRID UPDATED.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 13 SEALED 20GA X 1.16IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 4101329. A FUNCTIONAL TEST REVEALED THAT THE NEEDLE OF ONE UNIT FAILED TO FULLY RETRACT. THE FLASH NOTCH STOPPED AT THE BLOOD CONTROL VALVE. THE REMAINING WALL THICKNESS OF THE FLASH NOTCH WAS FOUND TO BE BELOW THE SPECIFICATION, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR OF THE REPORTED ISSUE. DURING MANUFACTURING, THIS MAY OCCUR DUE TO AN INCORRECT AMOUNT OF LUBE ON THE CANNULA. INCORRECT EQUIPMENT SETTINGS MAY CAUSE LUBE TO NOT BE APPLIED TO THE CANNULA, CAUSING DIFFICULTIES WHEN REMOVING IT FROM THE CATHETER OR RETRACTING THROUGH THE SEPTUM. QUALITY CONTROL PLAN VISUAL INSPECTION, AND SENOR FAULT HOMING SEQUENCES ARE PERFORMED TO MITIGATE THE OCCURRENCE OF THIS DEFECT. 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

    (B)(6) 2024: IT IS STATED THAT 'NOT ABLE TO USE IV AND GAIN ACCESS ON PATIENTS.' I¿M UNSURE WHERE THIS STATEMENT ORIGINATED. WE WERE ABLE TO USE PIV FROM DIFFERENT LOT NUMBER. WHAT WAS DONE TO COMPLETE THE TREATMENT? WE WERE ABLE TO USE PIV FROM DIFFERENT LOT NUMBER. WAS THERE ANY SERIOUS (LIFE THREATENING) INJURY AS A RESULT OF THE REPORTED EVENT? NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20G INSYTE IV CATHETERS NOT RETRACTING PROMPTLY WHEN SAFETY NEEDLE RETRACTION DEVICE IS ACTIVATED. NEEDLE SEEMS TO BE GETTING HUNG UP ON THE VALVE OF THE IV. WILL ONLY RETRACT WHEN CATHETER ADVANCED OFF OF NEEDLE, NOT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952967 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4101329 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown