BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD STERILIZATION POUCH

    MDR report key: 1742777 · Received June 30, 2010

    Report

    Report Number
    2084725-2010-00241
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 8, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    KCT
    PMA / PMN Number
    K951295
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), NO CODE AVAILABLE: POUCH PERFORATION ALIGNMENT. (B)(4). A DECISION WAS MADE BY THE ADVANCED STERILIZATION PRODUCTS (ASP) MANAGEMENT BOARD TO ISSUE A PRODUCT RECALL NOTICE TO A LIMITED NUMBER OF CUSTOMERS WHO RECEIVED PRODUCT FROM A NON-CONFORMING LOT OF THE TYVEK SELF-SEAL POUCH WITH STERRAD CHEMICAL INDICATOR SHIPPED BETWEEN (B)(6) AND (B)(6) 2010 IN SHIPMENTS OF CASES AND BETWEEN (B)(6) AND (B)(6) 2010 AS PART OF VALIDATION/TEST KITS. THE MANUFACTURER OF THE TYVEK SELF-SEAL POUCH WITH STERRAD CHEMICAL INDICATOR MISALIGNED THE PERFORATIONS OFTEN USED AS THE FOLDING POINT FOR THE SELF-SEALING AREA OF THE POUCH. AS A RESULT, THE SEAL MAY HAVE BEEN INCOMPLETE IN SOME OF THE POUCHES FROM THIS LOT.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER AND THE HEALTH HAZARD ANALYSIS, THE FAILURE MODE AND EFFECTS ANALYSIS, THE SYSTEM HAZARD AND USER MISUE ANALYSIS AND THE FAILURE INVESTIGATION REPORT. THE DHR (DEVICE HISTORY REVIEW) FOR TYVEK SELF SEAL POUCH WITH STERRAD CHEMICAL INDICATOR, LOT 2020 CONFIRMED THAT THERE WERE 388 CASES PRODUCED, 81 CASES KNOWN FROM PRODUCTION DATA TO BE ACCEPTABLE (2 ARE QUARANTINE), 307 CASES ARE POTENTIALLY AFFECTED BY THIS ISSUE. THE COMPLAINT HISTORY FOR THE TYVEK SELF SEAL POUCH WITH STERRAD CHEMICAL INDICATOR, LOT 2020 DID NOT REVEAL A TREND FOR "DEFECTIVE PART". TRENDING ANALYSIS FOR COMPROMISED STERILE BARRIER DUE TO INCORRECT PERFORATION LOCATION ON THE POUCH ISSUES DID NOT REVEAL ANY OTHER COMPLAINTS. THE HHE (HEALTH HAZARD ANALYSIS) RELATING TO COMPROMISED STERILE BARRIER DUE TO INCORRECT PERFORATION LOCATION ON THE POUCH IS CONSIDERED LOW AND NONE/NEGLIGIBLE. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND THE PRODUCT DESIGN WAS UPDATED. THE STERILE BARRIER WAS ABOVE THE THRESHOLD OF 100, INDICATING THAT FURTHER ACTION WAS REQUIRED IN TERMS OF MANUFACTURING CONTROLS AND UPDATING DRAWING SPECIFICATIONS. THE SHUMA (SYSTEM HAZARD AND USER MISUE ANALYSIS) WAS REVIEWED AND THE RISK WAS ASSESSED TO BE A CATEGORY 1 RISK (BROADLY ACCEPTABLE RISK). THE FIR (FAILURE INVESTIGATION REPORT ) RELATING TO COMPROMISED STERILE BARRIER DUE TO INCORRECT PERFORATION LOCATION ON THE POUCH DETERMINED THE ROOT CAUSE TO BE PROCESS FAILURE AT THE MANUFACTURING SITE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS INITIATED. THERE WAS ONE SHELF PACK OF TYVEK SELF SEAL POUCH WITH STERRAD CHEMICAL INDICATOR, LOT 2020, RETURNED FOR EVALUATION. THE PRODUCT WAS VISUALLY EXAMINED AND CONFIRMED THAT THE PERFORATION WAS IN THE WRONG LOCATION. THIS PARTICULAR FAILURE WAS ISOLATED TO THIS ONE LOT (LOT 2020). THE PERFORATION ON THE POUCH WAS IN THE WRONG LOCATION CAUSING THE ADHESIVE TONGUE SEAL OF THE POUCH TO SEAL BELOW THE POUCH OPENING. THIS, IN EFFECT, LEAVES AN INGRESS (PATHWAY) TO THE POUCH THROUGH PERFORATIONS AND SIDE FOLDS. THE PERFORATION BEING IN THE WRONG POUCH LOCATION ALSO RESULTS IN NO GUARANTEE OF STERILE POUCH CONTENTS DUE TO POTENTIAL INGRESS OF MICROORGANISMS. THE STERILE BARRIER IS CONSIDERED COMPROMISED. THE ROOT CAUSE FOR THIS ISSUE WAS DETERMINED TO BE PRODUCTION PROCESS FAILURE AT THE MANUFACTURING SITE. THE STEEL PERFORATION WHEEL HAD A MECHANICAL FAILURE. THERE WAS NO CONTROL POINT IN PLACE FOR CHANGE-OUT VERIFICATION AFTER THE WHEEL WEAR-OUT. AFTER THE PRODUCTION EQUIPMENT RESTART, THE OPERATOR DID NOT SET/ADJUST THE STEEL PERFORATION WHEEL TO THE CORRECT LOCATION AND CONTINUED WITH THE PRODUCTION OF THE POUCH LOT 2020. THERE WAS NO DOCUMENTATION / RECORDS THAT EXIST TO SHOW THE PROCESS MEASUREMENTS WERE PERFORMED AFTER REPLACING A NEW PERFORATION WHEEL DURING THE LOT RUN. THE PERFORATION DIMENSION LOCATION ON THE ENGINEERING DRAWING WAS NOT IDENTIFIED AS A CTQ - CONSIDERED A "REFERENCE DIMENSION" WHICH DOES NOT MANDATE THAT THE PERFORATION LOCATION IS MEASURED / DOCUMENTED DURING QUALITY CHECKS. ASP MADE THE DECISION TO ISSUE A PRODUCT RECALL NOTICE (RECALL NUMBER 2084725-06/23/2010-002R) TO A LIMITED NUMBER OF CUSTOMERS WHO RECEIVED THIS AFFECTED PRODUCT.

    Description of Event or Problem · 1

    DURING AN INSTALLATION PROCEDURE OF THE STERRAD NX AN ASP FIELD SERVICE ENGINEER (FSE) REPORTED AN ISSUE WITH THE VALIDATION KIT THAT INCLUDES PRODUCT (B)(4) (TYVEK SELF-SEAL POUCH WITH STERRAD CHEMICAL INDICATOR). THE FSE STATED THAT THE PERFORATIONS USED AS THE FOLDING POINT FOR THE SELF-SEALING AREA OF THE POUCH WERE MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD STERILIZATION POUCH STERILIZATION POUCH KCT ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 POUCH 6 X 12.5 CASE ((B)(4)) LOT# 2020