BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ INTIMA-II

    MDR report key: 17330440 · Received July 14, 2023

    Report

    Report Number
    2243072-2023-01237
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230640. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING UNSPECIFIED BD¿ INTIMA-II LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, WHEN THE PATIENT WAS UNDERGOING ENHANCED CT, THE HIGH-PRESSURE SYRINGE ALARMED, AND THE TECHNICIAN CHECKED AND FOUND BLOOD OOZING FROM THE MEMBRANE OF THE INDWELLING NEEDLE AND THE PIPELINE BURST. THE NURSE IMMEDIATELY REPLACED THE PATIENT'S LIMBS AND RE-INSERTED THE TUBE TO COMFORT THE PATIENT. THE PATIENT IS A RETIRED CADRE WITH SECONDARY SKIN DAMAGE AND HAS POOR MEDICAL EXPERIENCE. THE EVENT HAD SERIOUS ADVERSE EFFECTS ON THE PATIENT. AND THIS KIND OF SITUATION HAS HAPPENED MANY TIMES RECENTLY, SO IT WAS REPORTED TO THE DIRECTOR OF THE DEPARTMENT AND INFORMED THE MEDICAL OFFICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864709 UNSPECIFIED BD¿ INTIMA-II INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown