BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 9266718 · Received November 1, 2019

    Report

    Report Number
    3006948883-2019-00910
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 17, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050923. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A REVIEW OF THE MANUFACTURING PROCESS COULD NOT IDENTIFY ANY CONTRIBUTING FACTORS THAT COULD HAVE LEAD TO HE OBSERVED DAMAGE. BASED ON THE EVENT DESCRIPTION CITING FOUR DAYS OF USE WHERE THE DEVICE WAS OPERATING NORMALLY OUR QUALITY ENGINEERS HAVE DETERMINED THAT THE ROOT CAUSE FOR THIS EVENT IS UNRELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED DAMAGED/DEFECTIVE TUBING WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE Y-TYPE INTIMA-II EXTENSION TUBING WAS SUDDENLY COMPLETELY BROKEN WHEN THE PATIENT'S ARM WAS INDWELLING ON THE FOURTH NIGHT WITHOUT TRANSFUSION. THE PATIENT WAS OLD AND THE BLOOD WAS LEFT ON THE BED THROUGH THE EXTENSION TUBING, WHICH GREATLY FRIGHTENED THE PATIENT AND HIS FAMILY MEMBERS AND AFFECTED THE PATIENT'S CONDITION.

    Additional Manufacturer Narrative · 1

    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 INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED DAMAGED/DEFECTIVE TUBING WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE Y-TYPE INTIMA-II EXTENSION TUBING WAS SUDDENLY COMPLETELY BROKEN WHEN THE PATIENT'S ARM WAS INDWELLING ON THE FOURTH NIGHT WITHOUT TRANSFUSION. THE PATIENT WAS OLD AND THE BLOOD WAS LEFT ON THE BED THROUGH THE EXTENSION TUBING, WHICH GREATLY FRIGHTENED THE PATIENT AND HIS FAMILY MEMBERS AND AFFECTED THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059341 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9050923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other