BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.7MM 0.8MM 100CM DISPOSABLE ANGIOSCOPES

    MDR report key: 6391428 · Received March 9, 2017

    Report

    Report Number
    2027111-2017-01542
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    June 18, 2014
    Report Date
    March 9, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    LYK
    UDI-DI
    00607915111434
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING DETERMINED THAT THE UNIT FUNCTIONED PROPERLY AND MET ALL SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT NUMBER REVEALED THAT THE PRODUCT PASSED ALL QUALITY AND MANUFACTURING INSPECTIONS. THE EXACT ROOT CAUSE REMAINS UNKNOWN. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016. THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY((B)(6)). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    RT. FEMORAL - PERINEAL BYPASS- "MALFUNCTIONED- DID NOT FLUSH EVEN UNDER PRESSURE, OR SYRINGE." PATIENT STATUS - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174277 1.7MM 0.8MM 100CM DISPOSABLE ANGIOSCOPES LYK LYK APPLIED MEDICAL RESOURCES 1 1223242 00607915111434

    Patients

    Seq Age Sex Outcome Treatment
    1 ANOTHER ONE WAS USED