BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRIGATION SET, Y-TYPE

    MDR report key: 3788306 · Received April 25, 2014

    Report

    Report Number
    1417592-2014-00041
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPAIR OF A NICKED BLADDER, THE PT DEVELOPED HEMATURIA. CONTINUOUS BLADDER IRRIGATION WAS INITIATED. WITHIN 10 MINUTES, 3 LITERS OF FLUID HAD BEEN INFUSED INTO THE BLADDER THAT WAS REPORTED TO BE ALREADY WEAKENED. SUBSEQUENTLY, THE BLADDER RUPTURED AND THE PT WAS RETURNED TO THE OPERATING ROOM. FOR SURGICAL REPAIR. THE FACILITY REPORTED THAT THE DRIP CHAMBER FILLED COMPLETELY AND THE NURSE COULD NOT VISUALIZE THE FLOW RATE. THERE WAS NO SAMPLE RETAINED FOR EVALUATION AS THE INCIDENT OCCURRED TWO WEEKS PRIOR AND WAS NOT REPORTED AT THAT TIME. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US. IT IS NOT KNOWN IF THE IRRIGATION SET WAS CORRECTLY PRIMED WITH FLUID PRIOR TO USE. THE REPORTED AMOUNT OF SOLUTION LEAVING THE IRRIGATION BAG WAS SIGNIFICANT AND WOULD BE VISUALLY APPARENT TO A CLINICIAN. THE ROOT CAUSE APPEARS TO BE CLINICIAN ERROR. HOWEVER, IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILE.

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL REPAIR OF A NICKED BLADDER, CONTINUOUS BLADDER IRRIGATION WAS INITIATED. THE BLADDER RUPTURED AGAIN AND THE SURGEON INDICATED HE WAS NOT SURE IF THE CLINICIAN OR THE EQUIPMENT CONTRIBUTED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250470 IRRIGATION SET, Y-TYPE EYN MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R