BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3830007 · Received May 8, 2014

    Report

    Report Number
    3005778470-2014-00020
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    June 21, 2011
    Report Date
    June 21, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. FINAL QUALITY EVAL WAS CONDUCTED ON (B)(4) 2011 BASED ON THE INFO PROVIDED BY THE CUSTOMER AND SAMPLE RECEIVED WHICH WAS ONE BOX WITH 25 PCS OF BAGS. THE BOX IS MARKED WITH LABEL (15 958 8-CURI), INSIDE THE BOX THERE ARE BAGS OF ITEM (37 085 8-CURI). RESULTS ARE AS FOLLOWS: THE SAMPLE WAS TESTED AND DID NOT PERFORM TO OUR REQUIREMENTS. AN ANALYSIS TO DETERMINE THE POTENTIAL ROOT CAUSES INDICATES THAT THE MISTAKE OCCURRED DURING THE PACKING PROCESS DUE TO OPERATOR MISTAKE, WHO MOST LIKELY PACKED DIFFERENT TYPE OF BAGS INTO THE INNER BOXES. THE PROCEDURE FOR START-UP AND COMPLETION OF THE ORDER "LINE CLEARANCE" CONCERNING PACKAGING AND LABELING WAS NOT FOLLOWED. THE RESULTS WILL BE USED TO IMPLEMENT APPROPRIATE ACTIONS TO PREVENT THIS ISSUE FROM RECURRING. ALL RELEVANT PERSONNEL WHO WERE PACKING THE PRODUCTION ORDER IN QUESTION WILL BE RE-TRAINED ON LINE CLEARANCE PROCEDURE. ADDITIONALLY, WE HAVE IMPLEMENTED STRICT RULES FOR COMPLETING THE ORDER QUANTITY OF PRODUCTS IN BATCH (E.G. MISSING QUANTITY DUE TO INCREASED WASTE). IN CONCLUSION, THE APPROPRIATE PERSONNEL WILL BE CONTACTED TO VERIFY THAT PRODUCTS USED FOR BATCH COMPLETION ARE IN ACCORDANCE WITH THE SPECIFICATION AND DRAWING. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY (B)(4) FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO (B)(4) COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    INFO REF. ON THE COMPLAINT REPORT IS STATED AS FOLLOWS: "THE WRONG BAGS IN THE CARTONS, ITEM 8027 SHOULD BE INCLUDED ONLY 8019-370858-CURI IS PACKED IN THIS BOX. (WRONG PRODUCT IN BOX)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278276 URINARY DRAINAGE BAGS KIT, URINARY DRAINAGE COLLECTION FCN UNOMEDICAL S.R.O. 15 958 8-CURI 311041

    Patients

    Seq Age Sex Outcome Treatment
    1