BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6308 2000 ML DRAIN BG W/SPOUT

    MDR report key: 17483822 · Received August 8, 2023

    Report

    Report Number
    9612030-2023-03782
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 16, 2023
    Report Date
    October 31, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNX
    UDI-DI
    10884521002708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SILICONE CAP COVER IN A FOLEY BAG KIT. A 71 Y/O MALE WAS SENT TO THE ED WITH A 3 WAY FOLEY CATHETER IN PLACE. THE PATIENT PRESENTED WITH GROSS HEMATURIA AND A NEED FOR A BLOOD TRANSFUSION FOLLOWING A UROLOGY OFFICE VISIT. ADMISSION ORDERS WERE PLACED INCLUDING AN ORDER FOR BLADDER IRRIGATION. THE PATIENT WAS TRANSFERRED FROM THE ED TO 4 EAST AT 10:00PM WITH THE 3-WAY FOLEY CATHETER IN PLACE. UPON ARRIVAL THE FLOOR RN OBSERVED A DISTENDED ABDOMEN AND THE PATIENT WAS COMPLAINING OF PAIN. CONTINUOUS BLADDER IRRIGATION (CBI) FLUIDS WERE RUNNING BUT NO ACTIVE OUTPUT WAS NOTED. ATTEMPTS WERE MADE TO IRRIGATE THE FOLEY TO REMOVE CLOTS. THE NURSE NOTICED A CAP ON THE CATHETER BAG WAS INSERTED INTO THE OUTPUT PORT BLOCKING OUTPUT. THE CAP WAS REMOVED AND REPORTED TO HER SUPERVISORS. THE MEDICINE PROVIDER ORDERED PAIN MEDICATION AND CT ABDOMEN/PELVIS. AT 12:51, RESULTS OF THE CT SHOWED A POSSIBLE BLADDER PERFORATION. AT 01:27, THE PATIENT DEVELOPED TACHYCARDIA, LOW BLOOD PRESSURE AND WAS ADMITTED TO THE ICU. AT 6:00AM, TO OR EXPLORATORY LAPAROTOMY/CYSTOSCOPY (NOTE STATED PERFORATION OF BLADDER DUE TO OVER DISTENTION). PER ADDITIONAL INFORMATION, THE PATIENT HAD 2 ADDITIONAL PROCEDURES AFTER THE BLADDER REPAIR TO MANAGE HIS HEMATURIA AND ABNORMAL BLOODWORK (LOW HEMOGLOBIN, PLATELETS, ETC.). THE PATIENT WAS DISCHARGED TO HOSPICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344809 6308 2000 ML DRAIN BG W/SPOUT COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX CARDINAL HEALTH 6308LL 2303816164 10884521002708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention