BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 17140703 · Received June 15, 2023

    Report

    Report Number
    1710034-2023-00686
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 14JUN2023. H6: INVESTIGATION SUMMARY: BD RECEIVED A SEALED 20 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 3010271 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A BLACK PIECE OF FOREIGN MATTER (FM) LOOSE INSIDE OF THE BARREL. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DURING THE PACKAGING PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION HAS BEEN ISSUED TO ALL PACKAGING PERSONNEL TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ IV CATHETER FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023 DURING PACKAGING ACTIVITIES OF IOMERON 350 1 BTX 150 ML CTEXP TRS FR BATCH NUMBER LHP3651A, PHARMACEUTICAL OPERATORS FOUND 1 BD INSYTE AUTOGUARD 20G WITH A FOREIGN MATTER. INSIDE THE MEDICAL DEVICE. THE CATHETER BD INSYTE AUTOGUARD 20G DATA ARE REPORT BELOW: NUMBER OF OCCURRENCES PER BATCH LISTED: (B)(4). IMMEDIATE ACTION TAKEN: THE DEFECTIVE MEDICAL DEVICE WAS REJECTED AND NOT USED FOR PACKAGING OPERATIONS. THE PRESENT COMPLAINT WAS NOTIFIED BY E-MAIL TO BECKTON DICKINSON INFUSION THERAPY SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ IV CATHETER FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON MAY 15, 2023 DURING PACKAGING ACTIVITIES OF IOMERON 350 1 BTX 150 ML CTEXP TRS FR BATCH NUMBER LHP3651A, PHARMACEUTICAL OPERATORS FOUND 1 BD INSYTE AUTOGUARD 20G WITH A FOREIGN MATTER INSIDE THE MEDICAL DEVICE. THE CATHETER BD INSYTE AUTOGUARD 20G DATA ARE REPORT BELOW: NUMBER OF OCCURRENCES PER BATCH LISTED: 1 . IMMEDIATE ACTION TAKEN: THE DEFECTIVE MEDICAL DEVICE WAS REJECTED AND NOT USED FOR PACKAGING OPERATIONS. THE PRESENT COMPLAINT WAS NOTIFIED BY E-MAIL TO BECKTON DICKINSON INFUSION THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494539 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 3010271 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown