BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21426199 · Received February 20, 2025

    Report

    Report Number
    1710034-2025-00289
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 23, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DUE TO THE ABSENCE OF SAMPLES THAT EXHIBIT THE REPORTED CONDITION, WE WERE UNABLE TO CONDUCT A COMPREHENSIVE INVESTIGATION INTO THIS INCIDENT. NEVERTHELESS, THE DEFECT CONCERNING NEEDLE RETRACTION FAILURE HAS BEEN SUBSTANTIATED, AS A TREND HAS BEEN IDENTIFIED RELATED TO THIS FAILURE MODE, AND CORRECTIVE ACTION HAVE BEEN INITIATED TO FURTHER INVESTIGATE THIS INCIDENT AND ASCERTAIN THE ROOT CAUSE. AN EXAMINATION OF THE SPECIFIC PRODUCT INVOLVED MAY YIELD INSIGHTS INTO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES LINKED TO THIS ISSUE DURING THE PRODUCTION OF THE BATCH IN QUESTION.

    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. CUSTOMER CONFIRMS THAT SHE HAS FILED THIS COMPLAINT WITH BD IN THE PAST BUT IS UNABLE TO PROVIDE THE COMPLAINT # PROVIDED. CONSERVATIVELY FILING AGAIN AS WE ARE NOT ABLE TO LINK THE MEDSUN REPORT TO THE ORIGINAL COMPLAINT REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE IS NOT RETRACTING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 24-GAUGE IV CATHETER DID NOT RETRACT PROPERLY. (B)(6) 2025 9:12 AM: 1. WHAT WAS THE IMPACT TO THE PATIENT? NO. 2. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? NOT DURING PATIENT USE, DURING A TRAINING CLASS. NO INJURY OCCURRED. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 4. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025. 5. MATERIAL [381812] WAS NOT FOUND FOR LOT# 4072326. KINDLY VERIFY IF THERE IS ANY TYPO. LOT# 4072326 IS MATCHING WITH MATERIAL [381412] IN OUR SYSTEM. LOT 4229661. 6. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? ITEM NOT AVAILABLE. 7. WAS THIS INCIDENT REPORTED TO BD EARLIER? IF YES PLEASE PROVIDE COMPLAINT REFERENCE NUMBER. YES, BUT DO NOT HAVE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407636 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown