BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ TRI-EXTENSION SET

    MDR report key: 16210362 · Received January 19, 2023

    Report

    Report Number
    1710034-2023-00016
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 27, 2022
    Report Date
    February 1, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851584
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY SINCE NO PHOTOS OR SAMPLES DISPLAYING THE REPORTED CONDITION OF FLOW ISSUES - FLUID BLOCKAGE AND COMPONENT DAMAGE - NO LEAK WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR THE LOT NUMBER MATERIAL IDENTIFIED IN THIS COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE ONE OF THE EXTENSIONS ON THE BD Q-SYTE¿ TRI-EXTENSION SET WAS BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS COMPLAINING OF THE DEFECT IN ONE OF THE EXTENSIONS IN THE BD Q-SYTE TRI-EXTENSION SET.WHILE CUSTOMER PERFORMING FLUSHING OF ALL THREE EXTENSIONS ONE OF THE EXTENSION IS NOT WORKING AND FLUSH IS NOT GETTING FIXED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ONE OF THE EXTENSIONS ON THE BD Q-SYTE¿ TRI-EXTENSION SET WAS BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS COMPLAINING OF THE DEFECT IN ONE OF THE EXTENSIONS IN THE BD Q-SYTE TRI-EXTENSION SET. WHILE CUSTOMER PERFORMING FLUSHING OF ALL THREE EXTENSIONS ONE OF THE EXTENSION IS NOT WORKING AND FLUSH IS NOT GETTING FIXED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406820 BD Q-SYTE¿ TRI-EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2033442 00382903851584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown