BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    900012 DOVER URINE MTR & REPL BAG X10

    MDR report key: 12495168 · Received September 20, 2021

    Report

    Report Number
    1282497-2021-10623
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 4, 2021
    Report Date
    September 23, 2021
    Manufacturer
    COVIDIEN
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD THIS REPORT NUMBER, AS THIS REPORT WAS INADVERTENTLY FILED AS A MALFUNCTION; BASED ON THE REPORTED PRODUCT ID, CARDINAL HEALTH IS NOT CONSIDERED TO BE THE MANUFACTURER SUBJECT TO THE REPORTING REQUIREMENTS OF THE MDR REGULATION AND THEREFORE AN MDR SHOULD NOT HAVE BEEN GENERATED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT HAD A PROGRESSIVE CONTRACTION OF DIURESIS, PHARMACOLOGICALLY STIMULATED TO AVOID FLUID OVERLOAD. THE PATIENT WAS IN AN INTENSIVE THERAPY DEPARTMENT BUT AWAKE AND ABLE TO COMMUNICATE THIS PAIN FEELING. AFTER NOTICING THE REAPPEARANCE OF DIURESIS, DESPITE PHARMACOLOGICAL STIMULATION, THE CUSTOMER SUSPECTED THAT IT WAS THE URINOMETER PREVENTING THE EMISSION OF URINE. THE APPEARANCE OF BLADDER WAS GLOBUS AND PAIN WAS FELT BY THE PATIENT. AS SOON AS THE BLADDER CATHETER WAS DISCONNECTED FROM THE CLOSED CIRCUIT, DIURESIS RESUMED WITH 550 ML OF RESIDUE AND THE SAME AMOUNT EMITTED IN THE FOLLOWING HOUR. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395788 900012 DOVER URINE MTR & REPL BAG X10 COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX COVIDIEN 900012 202005154

    Patients

    Seq Age Sex Outcome Treatment
    1