BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8916301 · Received August 21, 2019

    Report

    Report Number
    3006948883-2019-00682
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 1, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023805. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT BLOOD LEAKAGE AT PRN DURING THE PROCESS OF PENETRATION. THE PATIENT WAS COUGHING AND COUGHING FOR MORE THAN 2 YEARS, AND HE WAS ADMITTED TO HOSPITAL IN (B)(6). HE WAS DIAGNOSED WITH ACUTE EXACERBATION OF CHRONIC BRONCHITIS. AFTER ADMISSION, HE WAS GIVEN AN INTRAVENOUS INFUSION OF COUGH AND PHLEGM AND ANTI-INFLAMMATORY DRUGS. AT (B)(6) 2019 10:02, HEMORRHAGE OCCURRED IN THE CLOSED VEIN OF THE HEMORRHAGIC CAP HEALIN CAP DURING THE PUNCTURE. THERE WAS A RISK OF INFUSION REACTION AND OCCUPATIONAL EXPOSURE. REPLACE THE INDWELLING NEEDLE HEPARIN AND EXPLAIN THE WORK TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT BLOOD LEAKAGE AT PRN DURING THE PROCESS OF PENETRATION. THE PATIENT WAS COUGHING AND COUGHING FOR MORE THAN 2 YEARS, AND HE WAS ADMITTED TO HOSPITAL IN JANUARY. HE WAS DIAGNOSED WITH ACUTE EXACERBATION OF CHRONIC BRONCHITIS. AFTER ADMISSION, HE WAS GIVEN AN INTRAVENOUS INFUSION OF COUGH AND PHLEGM AND ANTI-INFLAMMATORY DRUGS. AT (B)(6) 2019 10:02, HEMORRHAGE OCCURRED IN THE CLOSED VEIN OF THE HEMORRHAGIC CAP HEALIN CAP DURING THE PUNCTURE. THERE WAS A RISK OF INFUSION REACTION AND OCCUPATIONAL EXPOSURE. REPLACE THE INDWELLING NEEDLE HEPARIN AND EXPLAIN THE WORK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712932 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other