BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y18GAX1.16IN PRN/EC SLM

    MDR report key: 8965736 · Received September 5, 2019

    Report

    Report Number
    3006948883-2019-00730
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 17, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8080269. 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. A SAMPLE WAS SUBMITTED FOR EVALUATION AND TESTING, NO ABNORMALITIES COULD BE IDENTIFIED IN THE RETURNED SAMPLE DESPITE ATTEMPTS TO IDENTIFY THE CAUSE USING LEAKAGE TESTING AND MICROSCOPIC EVALUATION OF THE DEVICE. BASED ON SAMPLE INVESTIGATION, THE LEAKAGE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y18GAX1.16IN PRN/EC SLM EXPERIENCED LEAKAGE AT SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE USED THIS NEEDLE WHEN SHE RESCUED THE PATIENT. JUST AFTER THE SUCCESSFUL PUNCTURE, FOUND BLOOD OOZING AT THE ISOLATION PLUG.(SEPTUM) THE DEPARTMENT AND THE EQUIPMENT DEPARTMENT ARE VERY DISSATISFIED.

    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 Y18GAX1.16IN PRN/EC SLM EXPERIENCED LEAKAGE AT SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE USED THIS NEEDLE WHEN SHE RESCUED THE PATIENT. JUST AFTER THE SUCCESSFUL PUNCTURE, FOUND BLOOD OOZING AT THE ISOLATION PLUG (SEPTUM). THE DEPARTMENT AND THE EQUIPMENT DEPARTMENT ARE VERY DISSATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761863 INTIMA-II Y18GAX1.16IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8080269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other