BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8392573 · Received March 5, 2019

    Report

    Report Number
    3002682307-2019-00177
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    January 24, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171151. 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. 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 DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE. THE CUSTOMER REPORTED, ¿PATIENT FOUND LIQUID LEAKAGE NEAR PRN ON THE SECOND DAY, THEN CHANGE A NEW ONE."

    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 Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE. THE CUSTOMER REPORTED, ¿PATIENT FOUND LIQUID LEAKAGE NEAR PRN ON THE SECOND DAY, THEN CHANGE A NEW ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185511 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC NEEDLE FMF BECTON DICKINSON, S.A. 8171151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other