BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 400 SERIES 8 FRENCH

    MDR report key: 8116868 · Received November 29, 2018

    Report

    Report Number
    2320762-2018-00012
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 29, 2018
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD.
    Product Code
    EYC
    UDI-DI
    00749756045803
    PMA / PMN Number
    K041416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE DEVICE IS MANUFACTURED FOR (B)(4) BY (B)(4). A PHOTOGRAPH OF THE DEFECTIVE DEVICE WAS SENT TO (B)(4) FOR EVALUATION, AND THE MANUFACTURER DETERMINED THAT THE ROOT CAUSE WAS THE RESULT OF USE ERROR. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED FOR A FOLEY CATHETER (FINISHED GOOD 81-080408, LOT NOT PROVIDED) THAT CONTAINED A TEMPERATURE PROBE WIRE THAT WAS PROTRUDING FROM THE DEVICE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED. RAW MATERIAL AND FINISHED GOOD INVENTORY WERE CHECKED AND NO NON-CONFORMING PRODUCT WAS FOUND. A SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR EVALUATION. PHOTOS OF THE DEFECTIVE DEVICE WERE TAKEN AND SENT TO THE MANUFACTURER, (B)(4), FOR EVALUATION. THE VENDOR DETERMINED THAT THE CATHETER WAS PULLED STRONGLY, STRETCHING THE SILICONE SHAFT AND THERMOCOUPLE WIRE, WHICH CAUSED THE DEFORMATION. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO (B)(4). A RESPONSE HAS BEEN RECEIVED. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE TEMPERATURE PROBE WIRES WERE PROTRUDING FROM THE CATHETER, WHICH PLACED THE PATIENT AT RISK FOR SIGNIFICANT URETHRAL INJURY. THE CATHETER WAS REMOVED AND REPLACED, AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956425 FOLEY CATHETER, 400 SERIES 8 FRENCH CATHETER, UPPER URINARY TRACT EYC DEGANIA MEDICAL DEVICES PVT. LTD. 81-080408 NOT PROVIDED 00749756045803

    Patients

    Seq Age Sex Outcome Treatment
    1