BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10710212 · Received October 21, 2020

    Report

    Report Number
    3005483737-2020-00021
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 26, 2017
    Report Date
    October 19, 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 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 (THIS INCIDENT WAS INITIALLY REPORTED TO FDA BY DEGANIA SILICONE LTD. IN THE BORDERS OF RECALL ACTIVITY; REPORT # (B)(4). INCORRECT TEMPERATURE READING WAS CAUSED BY DEFECTIVE SENSORS, WHICH WERE PURCHASED COMPONENT. DEGANIA SILICONE PURCHASED AND ASSEMBLED THE SENSORS INTO ITS SILICON CATHETER. THE SUPPLIER OF THE SENSORS HAD PRODUCTION ISSUE, WHICH WAS NOT CAUGHT IN TIMELY MANNER. THE ISSUE WAS RELATED TO SENSOR TIP GRINDING OPERATION, IMPROPERLY PERFORMED BY NEWLY HIRED OPERATORS. DEGANIA SILICONE INITIATED FIELD SAFETY ACTION TO REMOVE FROM THE MARKET ITS TEMPERATURE SENSOR CATHETER LOTS, WHICH CONTAIN DEFECTIVE SENSORS. THIS INCIDENT WAS REPORTED TO FDA BY DEGANIA SILICONE LTD. REPORT # (B)(4).

    Description of Event or Problem · 1

    THIS IS RETROSPECTIVE SUBMISSION, FOLLOWING RE-ASSESSMENT OF OUR CUSTOMER COMPLAINTS DURING PERIOD 2018-2019. CUSTOMER'S TEXT: ACCORDING TO THE REPORTER, ON (B)(6) 2017, THE DEVICE HAD AN INACCURATE TEMPERATURE MEASUREMENT. THE PATIENT EXPERIENCED PAIN AFTER CHANGING THE CATHETER. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT. THERE WERE FOUR LOT NUMBERS MENTIONED IN THE COMPLAINT, TWO OF THEM INCORRECT TEMPERATURE READING, AND ANOTHER TWO FOR UNKNOWN FAILURE. THE LOT NUMBER INVOLVED ARE S17000191, S17001226, S16028702, S17000002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176914 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 S1700091

    Patients

    Seq Age Sex Outcome Treatment
    1