BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10225219 · Received July 2, 2020

    Report

    Report Number
    1710034-2020-00417
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 11, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/9/2020 . H.6. INVESTIGATION: BD RECEIVED TWO INSYTE AUTOGUARD BLOOD CONTROL 20 GAUGE UNITS FROM LOTS 9052990 AND 9177508 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED A PIECE OF FOREIGN MATTER ON THE NEEDLE TIPS. THE UNITS WERE THEN INSPECTED UNDER A MICROSCOPE AND THE FOREIGN MATTER WAS IDENTIFIED TO BE POROUS PLUG RESIDUAL FROM THE MANUFACTURING PROCESS. POROUS PLUG RESIDUALS ARE FRAGMENTS OF THE POROUS PLUG COMPONENTS AS THEY ARE PLACED IN THE HUB OF EACH UNIT. BASED OFF THE VISUAL AND MICROSCOPIC INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT. A NOTIFICATION HAS BEEN ISSUED TO ALL PERSONNEL INVOLVED IN THE MANUFACTURING OF THESE LOTS TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS' NEEDLES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATTER ON THE NEEDLE".

    Additional Manufacturer Narrative · 1

    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 FOREIGN MATTER WAS FOUND ON 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS' NEEDLES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATTER ON THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686487 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9052990

    Patients

    Seq Age Sex Outcome Treatment
    1 Other