BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13170971 · Received January 5, 2022

    Report

    Report Number
    3014704491-2021-00414
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    November 21, 2021
    Report Date
    January 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140312. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS TREATED WITH AUTOLOGOUS BLOOD TRANSFUSION OF TRIOXYGEN ON (B)(6) 2021 DUE TO PLANT NERVE DISORDER. BEFORE TREATMENT, ALL PARTS OF THE AUTOLOGOUS BLOOD TRANSFUSION WERE CONNECTED, AND THE INDIGNANT NEEDLE WAS FOUND TO BE STUCK AND STILL LEAKING FLUID WHEN DRAINING FLUID. A NEW INDIGNANT NEEDLE WAS REPLACED IN TIME TO PUNCTURE THE PATIENT WITHOUT CAUSING HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS TREATED WITH AUTOLOGOUS BLOOD TRANSFUSION OF TRIOXYGEN ON (B)(6) 2021 DUE TO PLANT NERVE DISORDER. BEFORE TREATMENT, ALL PARTS OF THE AUTOLOGOUS BLOOD TRANSFUSION WERE CONNECTED, AND THE INDIGNANT NEEDLE WAS FOUND TO BE STUCK AND STILL LEAKING FLUID WHEN DRAINING FLUID. A NEW INDIGNANT NEEDLE WAS REPLACED IN TIME TO PUNCTURE THE PATIENT WITHOUT CAUSING HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739862 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown