BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9428343 · Received December 6, 2019

    Report

    Report Number
    3006948883-2019-01039
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BD (SUZHOU)
    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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050837. 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, OUR ENGINEERS ATTEMPTED TO DUPLICATE THIS EVENT BY TESTING THE INTERACTION BETWEEN THE EXTENSION TUBING AND THE CONNECTED PINCH CLAMP. AFTER THIRTY ITERATIONS OF THIS TESTING OUR ENGINEERS WERE UNABLE TO DUPLICATE THE REPORTED FAILURE MODE. FIVE RETAINED SAMPLES WERE ALSO REVIEWED AND PASSED ALL SPECIFICATIONS. BASED ON OUR RESULTS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFECTIVE CLAMP WAS FOUND DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AFTER THE CT EXAMINATION AND THE SUCCESSFUL PUNCTURING, THE SEALING CLAMP WAS CLOSED AND BLOOD STILL FLOWED FROM THE PORT AFTER THE HEPARIN CAP WAS UNWOUND." 50 OCCURRENCES WERE REPORTED.

    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 DEFECTIVE CLAMP WAS FOUND DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AFTER THE CT EXAMINATION AND THE SUCCESSFUL PUNCTURING, THE SEALING CLAMP WAS CLOSED AND BLOOD STILL FLOWED FROM THE PORT AFTER THE HEPARIN CAP WAS UNWOUND." 50 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228905 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9050837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other