BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9718037 · Received February 17, 2020

    Report

    Report Number
    1710034-2020-00093
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE 24GA INSYTE AUTOGUARD BLOOD CONTROL IV CATHETER UNIT WITHIN AN UNDAMAGED OPENED PACKAGE FROM LOT NUMBER 9213332. ALL COMPONENTS ARE PRESENT, THE NEEDLE/HUB ASSEMBLY IS FULLY RETRACTED INTO THE BARREL. THROUGH THE VISUAL EXAMINATION, CLEAR STRANDS WERE OBSERVED AT AND NEAR THE TIP OF THE CATHETER TUBING THE REPORTED ISSUE WAS CONFIRMED. FURTHER SPECTRAL ANALYSIS OF THE FOREIGN MATTER DETERMINED THE MATERIAL OF CLEAR STRANDS TO BE CARDBOARD. IT IS POSSIBLE THIS FOREIGN MATTER WAS INTRODUCED FROM ENVIRONMENTAL FACTORS OR OPERATORS TRAVELING TO DIFFERENT ZONES WITH THE MANUFACTURING SITE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "STICKY BLOB" OF FOREIGN MATTER WAS FOUND ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YET ANOTHER STICKY BLOB ON A DIFFERENT ANGIOCATH."

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED THAT A "STICKY BLOB" OF FOREIGN MATTER WAS FOUND ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YET ANOTHER STICKY BLOB ON A DIFFERENT ANGIOCATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181918 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382512 9213332 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other