BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 16658878 · Received March 31, 2023

    Report

    Report Number
    1710034-2023-00341
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 13, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: IMDRF ANNEX A GRID: A0504. IMDRF ANNEX G GRID: G04023. IMDRF ANNEX B GRID: B15. IMDRF ANNEX C GRID: C13. H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 3002689, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE CATHETER TIP. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING THE ENGINEER COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE WENT THROUGH WHEN INSERTING IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE GOING THROUGH CATHETER WHEN INSERTING IV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE WENT THROUGH WHEN INSERTING IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE GOING THROUGH CATHETER WHEN INSERTING IV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE WENT THROUGH WHEN INSERTING IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE GOING THROUGH CATHETER WHEN INSERTING IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861595 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3002689 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown