BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD STERILIZATION POUCH

    MDR report key: 1622539 · Received March 4, 2010

    Report

    Report Number
    2084725-2010-00071
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    KCT
    PMA / PMN Number
    K951295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMMITTANT PRODUCTS: STERRAD 50 STERILIZER (B)(4). STRYKER LIGHT CORD (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER AND THE SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR THE STERRAD 50 SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 50 DID NOT REVEAL A TREND FOR DAMAGE TO CUSTOMER DEVICE. TRENDING ANALYSIS FOR DAMAGE TO CUSTOMER DEVICE ISSUES ASSOCIATED TO THE STERRAD 50 SHOWED THAT THERE WAS NO INCREASING DPMO TREND. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WAS REVIEWED FOR "LOAD DAMAGE," WHICH INCLUDES "DAMAGE TO CUSTOMER DEVICES." THE RISK IS CONSIDERED "BROADLY ACCEPTABLE RISK". THE DAMAGED DEVICE WAS NOT SENT TO ASP FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CUSTOMER DID NOT FOLLOW THE MANUFACTURER¿S PROCESSING INSTRUCTIONS. THE STRYKER LIGHT CORD USER MANUAL STATES, "DO NOT STERILIZE IN STERILIZATION POUCHES. DOING SO MAY RESULT IN DAMAGE TO THE DEVICE." THE DEVICE WAS NOT LISTED IN THE ASP STERRAD STERILITY GUIDE FOR THE STERRAD 50 AS OF 01/18/2011.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED DAMAGE TO A STRYKER LIGHT CORD THAT BONDED TO THE TYVEK POUCH AFTER IT WAS PROCESSED IN THE STERRAD 50 UNIT. THERE WAS NO REPORT OF INJURY TO A PATIENT OR A HEALTHCARE WORKER.

    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