BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8243974 · Received January 14, 2019

    Report

    Report Number
    3006948883-2018-00427
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 28, 2018
    Report Date
    January 22, 2019
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8141383, AND NO RELATED ABNORMALITIES WERE FOUND. THIS LOT OF INTIMA II WAS MANUFACTURED IN JUNE OF 2018; AND IT WAS DETERMINED THAT THIS IS THE SECOND INSTANCE THIS ISSUE OCCURRING IN THIS BATCH OF PRODUCT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR VISUAL INSPECTIONS. INVESTIGATION CONCLUSION: 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, DEPENDING ON PRESSURE VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO BECOME MISALIGNED ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE; A REVIEW OF OUR LINE DETERMINED THAT THE MACHINE IS IN THE PROPER ORIENTATION AND OPERATING NORMALLY. ROOT CAUSE DESCRIPTION: WE ARE CURRENTLY CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. RATIONALE: PRESENTLY, WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTIONS FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FUTURE OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING FLUSHING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 FLUSHING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37993 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other