BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 11821153 · Received May 13, 2021

    Report

    Report Number
    2320762-2021-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 11, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    UDI-DI
    00749756596664
    PMA / PMN Number
    K200757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SCAR WAS COMPLETED BY THE SUPPLIER; HOWEVER, NO ROOT CAUSE WAS ESTABLISHED DUE TO DEVICE NOT BEING RETURNED FOR SUPPLIER EVALUATION. PHOTOS PROVIDED WITH THE COMPLAINT SHOWED THE BALLOON WAS STILL INFLATED; HOWEVER, WITHOUT THE ABILITY TO INVESTIGATE THE DEVICE ITSELF. PER THE SUPPLIER (XERIDIEM), "POTENTIAL CAUSES FOR THE BALLOON TO REMAIN INFLATED AFTER ATTEMPT INCLUDE SHIPPING, STORAGE, MAINTENANCE, AND LIQUID USED TO INFLATE THE BALLOON. HOSPITALS MAY USE SALINE TO INFLATE THE BALLOON RATHER THAN WATER WHICH CAN CAUSE CRYSTALLIZATION OF THE SALINE WITHIN THE INFLATION LUMEN." XERIDIEM EXAMINED THE DEVICE HISTORY RECORDS FOR MANUFACTURING LOT #1011026103 AND FOUND NO COMPLAINTS RELATED TO SIMILAR FAILURES. DEROYAL HAS SOLD (B)(4) CASES OF FINISHED GOODS OF 81-080416EU IN THE PAST TWO YEARS WITH NO SIMILAR COMPLAINTS. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE WE WERE NOT ABLE TO COMPLETE A THOROUGH INVESTIGATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO VENDOR IN RELATION TO THE PRODUCT ISSUE; HOWEVER, STILL WAITING FOR COMPLETION. THE INVESTIGATION IS INCOMPLETE AT THIS TIME, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    UNABLE TO WITHDRAW REMAINING FLUID FROM THE CATHETER. MORE FLUID COULD BE INSERTED INTO THE BALLOON BUT NOT REMOVED. BALLOON REMAINED INFLATED WHEN WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714463 FOLEY CATHETER CATHETER EYC DEROYAL INDUSTRIES, INC. 81-080416EU 00749756596664

    Patients

    Seq Age Sex Outcome Treatment
    1