BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9788327 · Received March 4, 2020

    Report

    Report Number
    3006948883-2020-00075
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 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 9170827. 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 SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING THAT WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S SWAGE DIMENSIONS WERE MEASURED BY OUR TEAM AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. HOWEVER ACCORDING TO PREVIOUS INVESTIGATIONS, THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. TO ADDRESS THIS ISSUE THE MOLDING CAVITY HAS BEEN OPTIMIZED TO INCREASE RESILIENCE OF THE ADAPTER DURING THE SWAGING PROCESS . H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE WAS FOUND IN THE CATHETER SEAT PLACE DURING THE USE OF THE PRODUCT.

    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 WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE WAS FOUND IN THE CATHETER SEAT PLACE DURING THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253304 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 9170827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other