BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINER CANNSTR SUCT 3000CC DISP

    MDR report key: 1864556 · Received September 8, 2010

    Report

    Report Number
    1423507-2010-00039
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT SAMPLE WAS RETURNED AND A VISUAL INSPECTION OF THE 3000CC CRD LID WAS PERFORMED. THE UNIT EXHIBITED SEVERE DAMAGE INDICATIVE OF AN IMPLOSION EVENT WHERE THE LID WAS TOTALLY SEPARATED FROM THE SEAL SKIRT PERIMETER. THE LID SAMPLE SHOWED STRESS AND CRACKING AROUND THE POUR SPOUT AS WELL AS THE VACUUM, ORTHO, AND PATIENT PORTS. THE LID WAS VERIFIED TO BE THE OLD ITHAT DESIGN AND THE LID CAVITY NUMBER AS '3'. THE LOT NUMBER REPORTED, 10277009, IS NOT CONSISTENT WITH OUR LOT NUMBERING SYSTEM; THEREFORE, AN INVESTIGATION OF THE MANUFACTURING DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE LID DATE CODE WAS (B)(4) 2010, WHICH REPRESENTS THE DATE OF MANUFACTURE OF THE LID. IT WOULD BE EXPECTED THAT THE ASSEMBLY AND PACK OUT TIME FRAME WOULD ALSO BE AT ABOUT THIS TIME (-0/+2 MONTHS). A REVIEW OF SAMPLES MANUFACTURED DURING (B)(4) 2010 MEASURED THE LID THICKNESS TO BE 0.102 WHICH IS WITHIN CURRENT PRINT SPECIFICATION. THIS SAMPLE WAS ALSO SHOWN TO ENGINEERING PERSONNEL FOR EVALUATION. NO ADDITIONAL SPECIFIC ASSIGNABLE CAUSE COULD BE DETERMINED; HOWEVER, THEY DID NOTICE A SLIGHT INDENTION AROUND THE POUR SPOUT WHICH COULD BE DUE TO PART DAMAGE. A DAMAGED OR CRACKED LID WOULD NOT MEET THE REQUIREMENTS OF THE VACUUM STRESS ASSOCIATED WITH THE USE OF THE PRODUCT. THE FILTER APPEARED TO BE NON-STAINED SUGGESTING THAT THE UNIT HAD NOT BEEN PULLING LARGE AMOUNTS OF FLUID WASTE (I.E., UNIT EXPLODED PRIOR TO DRAWING FLUID OR DURING THE INITIAL STAGE OF THE PROCEDURE). THE 65651-530 CRD PRODUCT HAS UNDERGONE A DESIGN REVISION TO CHANGE THE LID MATERIAL FROM POLYSTYRENE TO POLYPROPYLENE. THE POLYPROPYLENE MATERIAL PROVIDES ADDITIONAL FLEXIBILITY AND WILL REDUCE THE RISK OF AN IMPLOSION EVENT. PRODUCT WITH THIS NEW DESIGN FEATURE WAS MANUFACTURED AND MADE AVAILABLE AFTER (B)(4) 2010. IT IS ALSO EMPHASIZED FOR INCREASED CUSTOMER AWARENESS ONLY, TO PERFORM A GENERAL CHECK FOR POSSIBLE HANDLING, PACKAGING, AND TRANSPORT DAMAGE PRIOR TO USE. IF DAMAGE IS NOTED, THE UNIT SHOULD BE DISCARDED AND REPLACED. IN A DISCUSSION WITH THE SALES REP, IT WAS NOTED THAT THE UNIT WAS BEING UTILIZED IN A TANDEM SETUP. THE CANISTER THAT IMPLODED WAS THE 1ST CANISTER IN THE TANDEM SET UP WITH ABOUT 500CC OF FLUID. THE VACUUM READING WAS OVER 500MMHG. THE PRODUCT LABELING, THROUGH SYMBOLS AND WORDING, DEFINES USAGE "FOR SINGLE USE ONLY" AND WARNS AGAINST PRODUCT BEING SUBJECTED TO STATIC VACUUM PRIOR TO USE FOR AN EXTENDED PERIOD. ALL UNITS THAT WERE SET UP IN TANDEM SHOULD BE DISCARDED AFTER THE PROCEDURE WHETHER THEY WERE UTILIZED FOR FLUID RETENTION OR NOT. WE WILL CONTINUE TO MONITOR CONCERNS SUCH AS THESE FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    LID TO THE SUCTION CANISTER IMPLODED INTO THE CANISTER AND MUST HAVE BUNCHED OUT AS THE CENTER OF THE LID IS BROKEN / CRACKED OFF CLEAN FROM THE LOCKING RING AND THE RING WAS STILL LOCKED INTO THE CANISTER. A NURSE WAS EXPOSED TO CONTENTS OF CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINER CANNSTR SUCT 3000CC DISP SUCTION CANISTER LINER KDQ CARDINAL HEALTH 65651-530 10277009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention