BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E HVLP MUR ICU KCC 8.0MM

    MDR report key: 5478192 · Received March 3, 2016

    Report

    Report Number
    9611710-2016-00011
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 4, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K050803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON MARCH 03, 2016. (B)(4). NOTE: THIS COMPLAINT REPORT IS FOR THE FIRST INSTANCE AND SINCE THIS ISSUE OCCURRED IN TWO (2) SEPARATE INSTANCES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER CASE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS IT WAS PROVIDED BY THE REPORTER THAT THE EVENT WAS ASSOCIATED WITH TWO DIFFERENT PATIENTS AND OCCURRED APPROXIMATELY ONE MONTH PRIOR. BOTH PATIENTS WERE FEMALE AND ONE PATIENT WAS IN THEIR 30'S, AND THE OTHER WAS IN THEIR 70'S. IT WAS STATED THAT BOTH PATIENTS HAD BEEN DISCHARGED. ALSO NOTED THAT NO PRODUCT SAMPLE WILL BE RETURNED FOR EVALUATION. FEMALE. NO FURTHER PATIENT/EVENT DETAILS HAVE BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IN ONE INSTANCE, THE PILOT LINE WAS FULLY CUT OFF AND THE CUFF STILL DID NOT DEFLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134166 E HVLP MUR ICU KCC 8.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35216

    Patients

    Seq Age Sex Outcome Treatment
    1