BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10723555 · Received October 22, 2020

    Report

    Report Number
    1710034-2020-00674
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNUSED UNIT IN AN OPENED PACKAGE FROM REF. 382533, LOT 0153311 AND TWO PHOTOS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. DURING THE VISUAL/MICROSCOPIC EXAMINATION, IT WAS OBSERVED THAT THERE WAS MORE SILICON THAT NORMAL ON THE TIP OF THE CATHETER TUBING CONFIRMING THE REPORTED DEFECT. ALTHOUGH NO QUALITY ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS, THE EXCESS SILICON IS LIKELY RELATED TO INCORRECT EQUIPMENT SETTINGS DURING THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOLDING DEFECT WAS FOUND ON THE TIP OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE APPEARS TO BE A SMALL DOT OF ADDITIONAL CATHETER MATERIAL AT THE TIP OF THE CATHETER."

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOLDING DEFECT WAS FOUND ON THE TIP OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE APPEARS TO BE A SMALL DOT OF ADDITIONAL CATHETER MATERIAL AT THE TIP OF THE CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188156 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 0153311 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other