BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8768961 · Received July 8, 2019

    Report

    Report Number
    3006948883-2019-00517
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 29, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050891& 9050885. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN EITHER PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE 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. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY (CAPA 642738) 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 FURTHUR OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE AT THE CATHETER/HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKAGE AT CATHETER HUB WAS NOTICED ONCE COMPLETED PUNCTURE ON PATIENT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9050885, MEDICAL DEVICE EXPIRATION DATE: 03/27/2022, DEVICE MANUFACTURE DATE: 02/19/2019. MEDICAL DEVICE LOT #: 9050891, MEDICAL DEVICE EXPIRATION DATE: 04/05/2022, DEVICE MANUFACTURE DATE: 02/19/2019. 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 TWO INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE AT THE CATHETER/HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKAGE AT CATHETER HUB WAS NOTICED ONCE COMPLETED PUNCTURE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559904 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC IV CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other