BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER S LID STANDARD

    MDR report key: 8187222 · Received December 20, 2018

    Report

    Report Number
    9610612-2018-00585
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    September 16, 2018
    Report Date
    December 20, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    KCT
    PMA / PMN Number
    K151242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: FAILURE DESCRIPTION - SEVERAL SCRATCHES CAN BE FOUND ON THE SURFACE OF ALL CONTAINER COMPONENTS, MOST LIKELY CAUSED BY WEAR AND TEAR. IN ADDITION, ONE CONTAINER BOTTOM AND LID WAS DISCOLORED IN BROWN/BLACK. NO DEVIATION WAS FOUND ON THE RETENTION PLACE AND THE FILTER. THE PROVIDED PARTICLES ARE GLUED ONTO A SHEET OF PAPER WITH ADHESIVE TAPE. INVESTIGATION - INVESTIGATION CARRIED OUT ON THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. IN SIMILAR COMPLAINTS, THE DETECTED BROWN/BLACK DISCOLORATION WAS TESTED AND HAD A NEGATIVE RESULT WITH FLUORIC ACID ON THE PRODUCT SURFACE. THIS LAYER (ELEVATED CHROME CONTENT) THROUGH OUR RESULTS CAN ONLY BE REMOVED MECHANICALLY, NOT BY ANY BASIC CLEANER OR OTHER CHEMICAL. IN MOST CASES THESE LAYERS ARE CREATED BY A CHEMICAL REACTION OF THE PRODUCT WITH THE PRODUCT SURFACE WITH PHOSPHOR-CONTAINING LIQUIDS, SUCH AS NEUTRALIZER BASE IN PHOSPHORIC ACIDS IN MACHINE CLEANING PROCESSES. DOSAGE ERRORS OR INSUFFICIENT RINSING MAY BE THE CAUSE. SUCH DISCOLORATION DOES NOT REDUCE THE LIFETIME OF THE PRODUCT NOR DOES IT REPRESENT A HYGIENIC RISK. A MATERIAL OR MANUFACTURING ISSUE WAS NOT DETECTED. ACCORDING TO THE IFU, STERILE CONTAINER S CAN USE HYDROGEN PEROXIDE FOR STERILIZATION. CERTAIN FRAGMENTS ARE MOST LIKELY FRAGMENTS OF CONTAINER FEET. THE BREAKAGE OF THESE FRAGMENTS WAS MOST LIKELY CAUSED BY EXTENSIVE FORCE, SINCE THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. OTHER FRAGMENTS ARE SMALL AND BLACK WHOSE ORIGIN IS YET UNKNOWN. IN THE CONTAINER SYSTEM THERE ARE 2 COMPONENTS MADE OF BLACK MATERIAL, THE FEET OF THE BASKET AND THE MECHANISM OF THE RETENTION PLATE. NEVERTHELESS, THE BLACK FRAGMENT COULD ALSO ORIGINATE FROM A DEVICE OR SIMILAR PRODUCTS DURING REPROCESSING. THERE WAS ONE GREY, SHINY FRAGMENT WHICH WAS MOST PROBABLY FROM ANOTHER DEVICE OR INSTRUMENT. IN 2016, A SIMILAR ISSUE WITH BLACK FLAKES IN STERILE CONTAINERS OCCURRED, CAUSED BY A WORN INJECTION-MOLDING TOOL. IN THIS CASE, A "VENDOR RELATED DEFECT" NOTIFICATION WAS CREATED AND CORRECTIVE ACTION WAS TAKEN. THERE WAS REWORK OF THE TOOL WITH AN OPTIMIZED DESIGN OF THE FOOT. SINCE (B)(6) 2017, NO MORE PRODUCTS WERE PRODUCED ACCORDING TO THE OLD PRODUCTION STANDARDS. ACCORDING TO THE IFU, NEW STERILE CONTAINERS MUST BE CLEANED PRIOR TO THE FIRST USE, TO WASH OUT FOREIGN OBJECTS. SINCE THE BASKET AND HENCE THE FEET WERE NOT AVAILABLE, WE CANNOT DETERMINE A FINAL ROOT CAUSE OF THIS FAILURE. NO MISSING PARTS OR DEVIATIONS CAN BE FOUND ON THE PROVIDED RETENTION PLATE. CONCLUSION AND ROOT CAUSE- BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONALE - THE BASKET AND FEET WERE NOT AVAILABLE, NOR THE DATE OF PRODUCTION. NEVERTHELESS, THERE ARE NEW FEET AVAILABLE SINCE (B)(6) 2017, THUS THE FEET AS THE ROOT CAUSE CAN BE EXCLUDED. IF THE FEET ARE OLDER THAN (B)(6) 2017, THE FAILURE WOULD HAVE OCCURRED EARLIER AND COULD HAVE BEEN PREVENTED BY WASHING IT OUT PRIOR TO THE FIRST USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT METAL SHAVINGS AND BLACK/GREY RESIDUE WERE FOUND IN THE BOTTOM OF AN INSTRUMENT CONTAINER. THE ISSUE WAS NOTED IN THE OPERATING ROOM BUT PRIOR TO USE OF THE CONTENTS IN THE STERILE FIELD. THERE WAS A 10-MINUTE DELAY IN SURGERY BUT THERE WAS NO PATIENT HARM OR INTERVENTION REQUIRED. THE CASE WAS A UROLOGY PROCEDURE. IT WAS FELT THAT THE REPETITION OF PLACING LIDS ON AND OFF THE BOTTOM MAY BE CAUSING THIS MALFUNCTION. THIS CASE REPRESENTS THE COMPONENT - CONTAINER LID STANDARD. ASSOCIATED MEDWATCHES: 9610612-2018-00584, 9610612-2018-00586, 9610612-2018-00587.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026870 STERILCONTAINER S LID STANDARD STERILIZATION CONTAINERS KCT AESCULAP AG JM489

    Patients

    Seq Age Sex Outcome Treatment
    1 FILTER POLYPROPYLEN RUND| FILTER RETENTION PLATE| INSTRUMENT BASKET