BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 19776030 · Received July 18, 2024

    Report

    Report Number
    1710034-2024-00741
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 15, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE PHOTOGRAPH AND 226 REPRESENTATIVE 22GA INSYTE AUTOGUARD UNITS FROM LOT: 4110695 WERE PROVIDED FOR INVESTIGATION. THE PHOTO DISPLAYS A NEEDLE THAT HAD PUNCTURED AND PROTRUDED THROUGH THE SIDE OF THE CATHETER TUBING. THE DAMAGE WAS NOT IDENTIFIED ON THE REPRESENTATIVE SAMPLES THAT WERE RECEIVED IN SEALED UNIT PACKAGING. AS THE PHOTO SHOWED THE DEVICE REMOVED FROM ITS PACKAGING, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    MATERIAL # 381423, BATCH # 4110695. IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER TIP WAS "SHEARED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CATHETER TIP APPEARS TO BE SHEARED. ADDITIONAL INFORMATION PROVIDED: CUSTOMER RESPONSE ON (B)(6) 2024. SEE ANSWERS TO YOUR QUESTIONS BELOW: DATE OF INCIDENT - (B)(6) 2024. WAS THIS USED ON A PATIENT -YES. ANY PATIENT HARM ¿UPTICK IN IV INFILTRATIONS, VERY MUCH DISCOMFORT FOR THE PATIENTS THAT TYPICALLY ISN'T THERE. ARE SAMPLES AVAILABLE TO BE RETURNED FOR ANALYSIS ¿YES AND WE PULLED THE LOT IS THERE A CONTACT AT THE LOCAL XXXX SITE THAT I CAN CONNECT WITH TO DISCUSS ¿ YES. CUSTOMER RESPONSE ON (B)(6) 2024. TWO DATES OF EVENTS WERE PROVIDED, WAS THERE TWO EVENTS? THERE WERE MULTIPLE EVENTS OVER THE WEEKEND AND INTO THE FOLLOWING WEEK CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501475 BD INSYTE AUTOGUARD BL 22GA X 1.0IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4110695 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown