BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE SENSOR CATHETER

    MDR report key: 10778325 · Received November 3, 2020

    Report

    Report Number
    3005483737-2020-00028
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT IS FILED RETROSPECTIVELY FOLLOWING FDA OBSERVATION NUMBER 4 RECEIVED BY DEGANIA MEDICAL DEVICES PVT. LTD. DURING THE FDA INSPECTION OF 4-7 OF NOVEMBER 2019. THE OBSERVATION WAS RELATED TO THE FACT THAT DEGANIA MEDICAL DEVICES PVT. LTD. DID NOT ESTABLISH PROCEDURES FOR REPORTING MDRS TO FDA AS A MANUFACTURER. TILL THEN ALL COMPLAINTS RELATED TO THE DEVICES PRODUCED BY DMD WERE ASSESSED FOR MDR REPORTABILITY AND SUBMITTED AS NECESSARY TO FDA BY DEGANIA SILICONE LTD. ANOTHER Q MEDICAL DEVICES DIVISION CLOSELY AFFILIATED WITH DMD. DMD CAPA NUMBER 73/19 WAS ISSUED TO ADDRESS THE OBSERVATION; ONE OF THE CAPA ACTIONS REQUIRES DMD TO PERFORM RETROSPECTIVE REVIEW OF ALL THE COMPLAINTS RECEIVED DURING 2018 AND 2019 AND SUBMIT TO FDA RETROSPECTIVE MDRS FOR THE REPORTABLE EVENTS (WITH REFERENCE TO ORIGINAL MDR REPORT 8030107-2020-00029 FILED BY DEGANIA SILICONE LTD.) THE BATCH REVIEW V18051110 REPORTED TO BE PRODUCED IN ACCORDANCE WITH THE PROCEDURE AND SPECIFICATION. NO NON CONFORMITIES REPORTED DURING THE PRODUCTION. THE CATHETERS PASSED 100% VISUAL INSPECTION. DURING THE EVALUATION OF THE ACTUAL SAMPLE WE OBSERVED MINOR BUBBLES ON THE CONNECTOR, THOSE ARE NOT HOLES AND DO NOT EXCEED THE SIZE OF BUBBLES ALLOWED BY THE SPECIFICATION WHICH DO NOT REQUIRE CAPA. THE SIGN ON THE CATHER'S FUNNEL DOES NOT REPERESENT DEFECT.

    Description of Event or Problem · 1

    THIS IS A RETROSPECTIVE REVIEW OF COMPLAINT 2018-2019 CUSTOMER TEXT: "ONE COMPLAINT SAMPLE RECEIVED WITH DEFECT DESCRIPTION, PIN HOLE FOUND ON THE CATHETER AND ON THE CONNECTOR. THE PICTURE ALSO RECEIVED THE HOLE AT FUNNEL IS INJECTION POINT SO IT IS NOT A DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241931 TEMPERATURE SENSOR CATHETER TEMPERATURE SENSING CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 14 FRENCH V18051110

    Patients

    Seq Age Sex Outcome Treatment
    1