BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 9767821 · Received February 28, 2020

    Report

    Report Number
    1710034-2020-00124
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE 22GA INSYTE AUTOGUARD IV BLOOD CONTROL CATHETER UNIT WITHIN AN UNDAMAGED OPENED PACKAGE FROM LOT NUMBER 9212069. ALL COMPONENTS WERE PRESENT, AND THE NEEDLE/HUB ASSEMBLY WAS FULLY RETRACTED INTO THE BARREL. IN ADDITION, ONE PHOTOGRAPH WAS SUBMITTED WHICH DISPLAYED THE CATHETER UNIT WITHOUT THE NEEDLE COVER. THE UNIT REVEALED A PIECE OF FOREIGN MATTER AT THE TIP OF THE CATHETER AND NEEDLE. THROUGH THE VISUAL EXAMINATION OF THE UNIT, FOREIGN MATTER WAS LOOSE INSIDE THE PACKAGE. THE FOREIGN MATTER HAS CHARACTERISTICS OF CLEAR FIBER STRANDS THAT ARE SOILED. FURTHER SPECTRAL ANALYSIS WAS PERFORMED WHICH ESTABLISHED THAT THE FOREIGN MATTER IN THIS INCIDENT WAS MOST LIKELY CELLULOSE AND LIGNIN. THERE WAS ALSO PRESENCE OF SILICONE WHICH IS USED IN THE LUBRICATION PROCESS OF THE CATHETER AND IS A KNOWN NON-FOREIGN. THE REPORTED ISSUE WAS CONFIRMED. THE FOREIGN MATTER WAS CONFIRMED TO CONTAIN CELLULOSE, LIGNIN AND SILICONE 360. SILICONE 360 IS EXPECTED TO BE FOUND ON THE CATHETER AND IS NOT CONSIDERED TO BE A FOREIGN MATTER. CELLULOSE AND LIGNIN ARE A PART OF THE TERRY WIPERS USED FOR SURFACE CLEANING IN THE MANUFACTURING AREAS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN INCIDENT OF A DEFECTIVE IV NEEDLE AT UMMC - BARD INSYTE AUTOGUARD BC, 22GAUGE X 1", LOT #9212069. (SEE PIC) "¿ WE OPENED AN IV CATHETER AND THERE WAS A PIECE OF CARDBOARD OR SOMETHING STUCK TO THE END OF THE NEEDLE. I SAVED IT BECAUSE IT WAS SO STRANGE.""

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN INCIDENT OF A DEFECTIVE IV NEEDLE AT (B)(6) - BARD INSYTE AUTOGUARD BC, 22GAUGE X 1", LOT #9212069. "¿ WE OPENED AN IV CATHETER AND THERE WAS A PIECE OF CARDBOARD OR SOMETHING STUCK TO THE END OF THE NEEDLE. I SAVED IT BECAUSE IT WAS SO STRANGE.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235601 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 9212069 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other