BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 11998430 · Received June 15, 2021

    Report

    Report Number
    2320762-2021-00005
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 31, 2021
    Report Date
    August 3, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    UDI-DI
    00749756045766
    PMA / PMN Number
    K200757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SCAR WAS COMPLETED HOWEVER THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE DEFECT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE REMAINS UNDETERMINED. THE SUPPLIER'S DEVICE HISTORY RECORD OF A SEPERATE LOT #1038301 WAS REVIEWED OF ALL LINE CLEARANCES, MATERIAL VERIFICATIONS AND QC INSPECTIONS AND FOR SUB-ASSEMBLY MANUFACTURING BY THE SUPPLIER'S TRAINED AND CERTIFIED STAFF. THERE WAS NO SCRAP RELATED TO THE DRAINAGE LUMEN AND THERE WERE NO NON-CONFORMING REPORTS GENERATED. ON 10/28/2020, THERE WERE (B)(4) FINISHED DEVICES RELEASED TO SPECIFICATION. HOWEVER, TWO COMPLAINTS WERE FOUND FOR PLUGGED DRAINAGE LUMEN IN THIS LOT. FOR PREVIOUS YEAR ((B)(6) 2020- (B)(6) 2021) THREE COMPLAINTS FOR PLUGGED DRAINAGE LUMEN WERE REPORTED. SUPPLIER CORRECTIVE ACTION: TRAINING WITH OPERATORS RELATED TO DETECTION OF SPLASH IN THE DRAINAGE LUMEN WAS COMPLETED ON (B)(6) 2021. DEROYAL'S ENGINEERING DEPARTMENT PERFORMED TESTING ON FOURTEEN SAMPLES OF THE FINISHED GOOD #81-080416. FOUR SAMPLES WERE FROM THE CUSTOMER'S REMAINING UNUSED CATHETERS (LOT #54121772), AND TEN FROM DEROYAL'S DISTRIBUTION CENTER (LOT #54821841). ALL SAMPLES PASSED FOR STATIC LOAD TEST OF INFLATED BALLOON RESPONSE TO TRACTION. THIRTEEN OUT OF FOURTEEN PASSED FOR IMPACT LOAD TEST AND LEAK TEST. ONE CATHETER FAILED BY FILLING 10CC MORE THAN SPECIFIED AMOUNT MOST LIKELY DUE TO AN ERROR WHILE HANDLING THE CATHETER PRIOR TO TESTING. FOUR OF SAMPLES LOT #54121772 CATHETER AND FIVE OF SAMPLES LOT #548217841 PASSED FLOW RATE TEST ABOVE THE MINIMUM REQUIREMENT. BASED ON THE TESTING PERFORMED, THE PRODUCTS WERE NOT FOUND TO BE DEFECTIVE. DEROYAL HAS SOLD (B)(4) CASES IN THE LAST TWO YEARS WITH ONE SIMILAR COMPLAINT OF PLUGGED LUMEN. 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 (B)(4) IN RELATION TO THE PRODUCT ISSUES; 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

    DURING DAY ZERO OF POST-OPERATION, THE PATIENT WAS SHOWING WITH NO URINE OUTPUT IN OPERATING ROOM. WHEN ASSESSED BY THE NURSE BY A BLADDER SCANNER HE HAD 350 ML IN HIS BLADDER DESPITE HAVING A FOLEY CATHETER INSITU. THIS WAS IRRIGATED AND URINE CLEAR OF CLOTS CAME OUT. LOW VOLUMES OF URINE CONTINUED TO DRAIN IN THE FOLLOWING 12 HOURS, HOWEVER THE PATIENT WAS EXPERIENCING INCREASING ABDOMINAL PAIN AND URGE TO VOID. WHEN ASSESSED THE CATHETER WAS UNABLE TO IRRIGATE, AND THE BLADDER SCAN SHOWED RESIDUAL URINE IN THE BLADDER. THE FOLEY CATHETER WAS REMOVED AND THE PATIENT WAS INCONTINENT OF LARGE AMOUNTS OF URINE. THIS PATIENT EXPERIENCES SIGNIFICANT AND PAINFUL URINARY RETENTION DESPITE THE CATHETER BEING INSITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896945 FOLEY CATHETER CATHETER EYC DEROYAL INDUSTRIES, INC. 81-080416 54121772 00749756045766

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR