BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 3908224 · Received May 30, 2014

    Report

    Report Number
    3005778470-2014-00033
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FCN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. FINAL QUALITY EVALUATION WAS CONDUCTED ON (B)(4) 2011 BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. NO SAMPLE WAS AVAILABLE FOR EVALUATION; HOWEVER, OUR INTERNAL INVESTIGATION SHOWS THAT ON RARE OCCASIONS DIFFERENT KIND OF PRODUCT IS PACKED INTO THE BOXES. THE MISTAKE WAS CAUSED BY OPERATORS INATTENTION, THEY DID NOT CHECK THE ITEM NUMBER OF PACKED PRODUCTS. IN CONCLUSION, THE INVESTIGATION OF THIS MATTER HAS BEEN DONE PREVIOUSLY AND THE RESULTS ARE AVAILABLE IN A DOCUMENTED CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) EVENT. THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - SEPTEMBER 30, 2013. REPORTED TO THE FDA ON 05/29/2014. NOTE: THE ACTUAL DATE OF EVENT 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: "WRONG ITEM IN THE BOX, 2040 INSTEAD OF 2048."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320035 URINARY DRAINAGE BAG KIT, URINARY DRAINAGE COLLECTION FCN UNOMEDICAL S.R.O. 24 151 8-CURI 396316

    Patients

    Seq Age Sex Outcome Treatment
    1