BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC WING

    MDR report key: 20626298 · Received November 7, 2024

    Report

    Report Number
    1710034-2024-01283
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 17, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS UPDATED IN E TAB. INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 3 UNSEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721. ALL 3 UNITS WERE RECEIVED RETRACTED AND WITH MEDIA. NO CATHETER WAS PROVIDED. A VISUAL INSPECTION WAS PROVIDED FOR ANY DAMAGES TO THE SPRING, NEEDLE HUB, BARREL, CANNULA, BUTTON, OR DRY ADHESIVE. NO DAMAGES WERE DISCOVERED. THE UNITS WERE PLACED BACK INTO INITIAL POSITION AND THE BUTTON WAS ACTIVATED. ALL 3 UNITS RETRACTED SUCCESSFULLY AND IN LESS THAN 1 SECOND. WE WERE UNABLE TO CONFIRM YOUR REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA #.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I WAS GIVEN 5 MORE (9 + CATHETERS FAILING TOTAL) FROM THE NWCH ED - THEY ARE ALL THE SAME LOT # 422721. I WAS ALSO TOLD ACUTE CARE AND OR HAVE HAD ¿STICKY¿ ISSUES WITH NEEDLE RETRACTION. THEY HAVE NOT SAVED THEM NOR, PUT IN A SAFE CONNECT. THE NURSE MANAGER OF ACUTE SUPPLIED THESE LOT NUMBERS IN USE AT THIS TIME: WEST: 4220015, 4222721 EAST: 4123610, 4102957, 3361863, 4037545. NO PACKAGING/DEVICES WERE SAVED ON THOSE UNITS.¿ NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990707 BD INSYTE AUTOGUARD BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown