BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9257641 · Received October 30, 2019

    Report

    Report Number
    1710034-2019-01159
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PICTURES PROVIDED. BD RECEIVED ONE UNUSED UNIT IN ITS ORIGINAL PACKAGING FROM LOT NUMBER 9071776. ONE PHOTO WAS ALSO RECEIVED. UPON VISUAL INSPECTION NO FOREIGN MATTER WAS OBSERVED ON THE UNIT. THROUGH MICROSCOPIC EVALUATION WE WERE ABLE TO CONFIRM FOREIGN MATTER ON THE CATHETER TUBING. THE FOREIGN MATTER APPEARS TO BE ON THE OUTSIDE OF THE CATHETER WALLS. THE UNIT WAS SENT FOR FURTHER FTIR TESTING. ONCE THE UNIT WAS RECEIVED FOR TESTING, FOREIGN MATTER WAS NO LONGER OBSERVED ON THE UNIT. UNFORTUNATELY, BD WAS UNABLE TO DETERMINE A ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE USER COMPLAINED THAT BLACK FOREIGN BODY WAS FOUND AT THE TIP OF THE CATHETER."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE USER COMPLAINED THAT BLACK FOREIGN BODY WAS FOUND AT THE TIP OF THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052583 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9071776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other