BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20630152 · Received November 7, 2024

    Report

    Report Number
    1710034-2024-01289
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 21, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTO OF TWO 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721 AND ONE 22GA X 1.00IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 4116716. THE PHOTO DOES NOT DISPLAY ANY UNIT. ONLY THE LABELING OF THE PACKAGES IS SHOWN IN THE PHOTO. THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE AS IT ONLY DISPLAYED THE TOP WEB LABEL. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED 11 SEALED AND 3 UNSEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721. ADDITIONALLY, ONE PHOTO WAS PROVIDED, WHICH SHOWED ONE 20G WINGED IV CATHETER AND THREE UNIT PACKAGES FROM LOTS 4116716 (22G), 4222721 (20G), AND 4057790 (20G). YOUR REPORT COULD NOT BE CONFIRMED FROM THE PHOTOGRAPH. THE 11 SEALED SAMPLES WERE TESTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND THEN ACTIVATING THE BUTTON. A STOPWATCH WAS ACTIVATED WHEN THE BUTTON WAS ACTIVATED AND STOPPED WHEN THE NEEDLE FULLY RETRACTED IN THE BARREL. THE FUNCTIONAL TEST SHOWED THAT THE UNUSED SAMPLES EXCEEDED THE SPECIFICATION FOR RETRACTION TIME THEREFORE CONFIRMING YOUR REPORTED ISSUE. THE CAUSE APPEARED TO BE MANUFACTURING RELATED DUE TO EXCESSIVE GEL IN THE CHAMBER. THE 3 UNSEALED PHYSICAL SAMPLES THAT WERE PROVIDED WERE ALREADY RETRACTED AND WITH NO CATHETERS PROVIDED. THE UNITS WERE PLACED BACK INTO INITIAL POSITION AND VISUALLY INSPECTED AND NO DAMAGES WERE DISCOVERED. THE UNITS RETRACTED SUCCESSFULLY. 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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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 WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSH BUTTON ON IAGBC IS SIGNIFICANTLY DELAYED IN RETRACTING THE NEEDLE, RISKING NEEDLE STICK TO THE NURSE. POTENTIAL NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625613 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 422272 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown