BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 8348281 · Received February 18, 2019

    Report

    Report Number
    3006948883-2019-00144
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 27, 2019
    Report Date
    March 13, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8305858. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A 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 CONFIRM THE ROOT CAUSE FOR THIS EVENT. HOWEVER, THE PREVIOUS INVESTIGATION IN TO LEAKAGE FOR THIS LOT SUGGESTS THAT THROUGH A VARIANCE IN PRESSURE FOR THE AUTOLINE'S SWAGE STATION, IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR A CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTIONS FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS. CAPA 642738.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139889 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER FOZ BD (SUZHOU) 8305858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other