BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 11427505 · Received March 7, 2021

    Report

    Report Number
    1710034-2021-00172
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED BLOOD LEAKAGE THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY BLOOD CONTROL VALVE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN. (0.9 X 25 MM) 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 THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED BLOOD LEAKAGE THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY BLOOD CONTROL VALVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324169 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0169672

    Patients

    Seq Age Sex Outcome Treatment
    1