BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC

    MDR report key: 12380395 · Received August 27, 2021

    Report

    Report Number
    3014704491-2021-00107
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    September 3, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111472. 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. ADDITIONALLY, THE SAMPLE SUBMITTED BY THE FACILITY, TO AID IN OUR INVESTIGATION, HAS BEEN REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. BASED ON VISUAL ANALYSIS OF THE DEVICE, OUR ENGINEERS DETERMINED THAT THE BENT TUBING IS RELATED TO THE PACKAGING PROCESS AND RESULTS FROM OPERATOR ERROR.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED FIVE INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AFTER PEDIATRIC UNPACKING, THE EXTENSION TUBE WAS FOUND TO BE BROKEN".

    Description of Event or Problem · 0

    IT WAS REPORTED FIVE INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AFTER PEDIATRIC UNPACKING, THE EXTENSION TUBE WAS FOUND TO BE BROKEN"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275176 INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC INTRAVASCULAR CATHETER FPA 1111472

    Patients

    Seq Age Sex Outcome Treatment
    1