BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    MDR report key: 8977597 · Received September 9, 2019

    Report

    Report Number
    2320762-2019-00006
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 8, 2019
    Report Date
    January 6, 2020
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    EYC
    UDI-DI
    50749756045808
    PMA / PMN Number
    K041416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE SILICONE CATHETER PORTION OF THE DEVICE IS MANUFACTURED BY DEGANIA SILICONE. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO DEGANIA. IN ITS RESPONSE, DEGANIA STATED A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON EXAMINATION OF THE DEFECTIVE SAMPLE, IT IS POSSIBLE THE CATHETER MALFUNCTIONED AS A RESULT OF IMPROPER TREATMENT OF THE DEVICE DURING USE (I.E. EXCESSIVE FORCE DURING REMOVAL). CORRECTIVE ACTION: IN ITS SCAR RESPONSE, DEGANIA STATED NO CORRECTIVE ACTIONS ARE BEING TAKEN AT THIS TIME. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED FOR A FOLEY CATHETER WITH TEMPERATURE SENSOR (PART 81-080408) THAT WAS FOUND CRACKED IN A PATIENT'S DIAPER WITH THE BALLOON DEFLATED. THE PRODUCT WAS BEING USED TO MONITOR THE PATIENT'S TEMPERATURE. THE DEFECTIVE SAMPLE WAS RETURNED AUGUST 23, 2019 FOR EVALUATION. THE RETURNED SAMPLE CONFIRMED THE END USER'S COMPLAINT. THE SILICONE CATHETER PORTION OF THE DEVICE IS MANUFACTURED BY DEGANIA SILICONE. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS SENT TO DEGANIA AS WELL AS THE DEFECTIVE SAMPLE. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. A REVIEW OF SALES AND SIMILAR COMPLAINT INFORMATION SHOWED THAT DEROYAL HAS SOLD (B)(4)CASES OF THE FINISHED GOOD PRODUCT FROM (B)(6) 2017 TO PRESENT. DURING THIS REVIEW PERIOD, FIVE COMPLAINTS WERE RECEIVED FOR THE SAME PRODUCT, WHICH EQUATES TO A COMPLAINT-TO-SALES RATIO OF 0.032. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    WHEN THE BABY'S DIAPER WAS OPENED, THE FOLEY CATHETER WAS FOUND CRACKED WITH THE BALLOON DEFLATED. THE CATHETER HAD FALLEN APART. THE PRODUCT WAS BEING USED TO MEASURE THE PATIENT'S BODY TEMPERATURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED FOR A FOLEY CATHETER WITH TEMPERATURE SENSOR (PART 81-080408) THAT WAS FOUND CRACKED IN A PATIENT'S DIAPER WITH THE BALLOON DEFLATED. THE PRODUCT WAS BEING USED TO MONITOR THE PATIENT'S TEMPERATURE. THE DEFECTIVE SAMPLE WAS RETURNED (B)(6) 2019 FOR EVALUATION. THE SILICONE CATHETER PORTION OF THE DEVICE IS MANUFACTURED BY DEGANIA SILICONE. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS SENT TO DEGANIA AS WELL AS THE DEFECTIVE SAMPLE. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    WHEN THE BABY'S DIAPER WAS OPENED, THE FOLEY CATHETER WAS FOUND CRACKED WITH THE BALLOON DEFLATED. THE CATHETER HAD FALLEN APART. THE PRODUCT WAS BEING USED TO MEASURE THE PATIENT'S BODY TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767799 FOLEY CATHETER WITH TEMPERATURE SENSOR CATHETER, UPPER URINARY TRACT EYC DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. 81-080408 NOT PROVIDED 50749756045808

    Patients

    Seq Age Sex Outcome Treatment
    1