BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER

    MDR report key: 10806355 · Received November 8, 2020

    Report

    Report Number
    3005483737-2020-00034
    Event Type
    Malfunction
    Date Received
    November 8, 2020
    Report Date
    November 8, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(4) 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 REPORTED TO FDA IN THE BORDERS OF RECALL ACTIVITY; REPORT# (B)(4). INCORRECT TEMPERATURE READING WAS CAUSED BY DEFECTIVE SENSORS, WHICH ARE PURCHASED COMPONENT. DEGANIA SILICONE PURCHASED AND ASSEMBLED THE SENSORS INTO ITS SILICONE CATHETER. IT WAS EXPLAINED BY THE SUPPLIER OF SENSORS, THAT THE CRACKS IN DEFECTIVE THERMISTOR TIP DID NOT APPEAR IMMEDIATELY BUT DEVELOPED FOLLOWING IMPACT OF DIFFERENT FACTORS LIKE TIME, TRANSPORTATION CONDITIONS, HUMIDITY. THIS IS THE REASON THE INPROCESS DEGANIA TESTS DID NOT DETECT THE PROBLEM. CORRECTIVE AND PREVENTIVE ACTION HAS ALREADY BEEN TAKEN AT SUPPLIER END. IMPROVED CONTROL OF GRINDING QUALITY BY LINE LEADERS AND QC STAFF. IMPROVED VISUAL AIDS ARE PUT ON WORKING STATION. AQL ACCEPTANCE CRITERIA OF INCOMING SENSORS WILL BE CHANGED BY DEGANIA.

    Description of Event or Problem · 1

    THIS IS RETROSPECTIVE SUBMISSION, FOLLOWING REASSESSMENT OF OUR CUSTOMER COMPLAINTS DURING PERIOD 2018-2019. CUSTOMER'S TEXT: "ACCORDING TO THE REPORTER, DURING USE, THE DEVICE PROVIDED INACCURATE TEMPERATURE. THERE WAS NO REPORTED PATIENT OUTCOME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271152 MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 14 FRENCH S17007599

    Patients

    Seq Age Sex Outcome Treatment
    1