BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3908210 · Received May 29, 2014

    Report

    Report Number
    3005778470-2014-00032
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FCN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. AN INVESTIGATION WAS CONDUCTED ON (B)(4) 2011 BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND SAMPLE(S) RECEIVED. THE SAMPLE PROVIDED WAS TESTED AND DID NOT PERFORM TO OUR REQUIREMENTS. AN ANALYSIS TO DETERMINE THE POTENTIAL ROOT CAUSE INDICATES THAT THE MISTAKE WAS CAUSED BY OPERATOR INATTENTION. IT IS CONCLUDED THAT THE OPERATORS DID NOT CHECK THE ITEM NUMBER OF PACKED PRODUCTS. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM MAY 01, 2011 - SEPTEMBER 30, 2013. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT (B3) IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF COMPLAINT: "CUSTOMER ORDERED (B)(6), RECEIVED A BOX MARKED WITH (B)(6) BUT PACKED WITH ANOTHER PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317416 URINARY DRAINAGE BAGS KIT, URINARY DRAINAGE COLLECTIONS FCN UNOMEDICAL S.R.O. 24 111 8-10 364888

    Patients

    Seq Age Sex Outcome Treatment
    1