BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 8352228 · Received February 19, 2019

    Report

    Report Number
    3006948883-2019-00145
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8305838. OUR RECORDS SHOW THAT THIS IS THE SECOND 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, BASED ON THE SAMPLE PROVIDED OUR QUALITY ENGINEERS WERE ABLE TO OBSERVE A SMALL CRACK IN THE ADAPTER. AFTER REVIEWING THE MANUFACTURING PROCESS THEY DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS 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. 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 24GAX0.75IN PRN SLM NPVC EXPERIENCED LEAKAGE ACCORDING TO CUSTOMER, "AT ROOT OF CATHETER DURING INFUSION.¿

    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 THE INTIMA-II 24GAX0.75IN PRN SLM NPVC EXPERIENCED LEAKAGE ACCORDING TO CUSTOMER, "AT ROOT OF CATHETER DURING INFUSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143324 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8305838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other