BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX CASSETTE

    MDR report key: 4182562 · Received October 17, 2014

    Report

    Report Number
    2084725-2014-00341
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: 07/09/2014. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH RECORD REVIEW, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE AND LOT NUMBER, AND SYSTEM HAZARD USER MISUSE ANALYSIS (SHUMA). METHOD - SERVICE HISTORY, TRENDING AND SHUMA REVIEWED. ¿THE BATCH RECORD REVIEW WAS REVIEWED AND NO ISSUES RELATING THE FAILURE MODE WERE NOTED. THE BATCH MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. ¿THE SERVICE HISTORY FOR THE PAST SIX MONTHS (04/05/2014 TO 10/02/2014) DID NOT IDENTIFY ANY SIGNIFICANT TREND. ¿THE TREND FOR THE PRODUCT MALFUNCTION CODE OF SKIN REACTION WAS ASSESSED FROM JANUARY 2014 THROUGH DECEMBER 2014. THE RISK IS CONSIDERED "ACCEPTABLE AFTER BEING REDUCED AS LOW AS POSSIBLE." ¿ TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 07/09/2014 TO 10/02/2014. THERE WERE NO SIMILAR INCIDENTS WITHIN THIS TIME FRAME. ¿THE SHUMA INDICATES THE RISK IS "BROADLY ACCEPTABLE." THE INSTRUCTIONS FOR USE (IFU) OF THE STERRAD® 100NX STATE: "WARNING! HYDROGEN PEROXIDE MAY BE PRESENT. WEAR CHEMICAL RESISTANT LATEX, PVC (VINYL), OR NITRILE GLOVES WHENEVER HANDLING A LOAD AFTER A CYCLE CANCELLATION OR WHEN DISPOSING OF A CASSETTE. HYDROGEN PEROXIDE LIQUID MAY BE PRESENT ON THE CASSETTE, THE LOAD OR IN THE CHAMBER." TESTING WAS NOT PERFORMED AS THERE WAS NO PRODUCT RETURNED. THE MOST LIKELY ASSIGNABLE CAUSE IS THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT'S IFU TO WEAR PPE WHEN HANDLING A USED CASSETTE. THE SEVERITY OF THE ISSUE WAS DEFINED AS "MODERATE." THE CUSTOMER WAS SENT A LETTER ADVISING TO REVIEW THE PROPER HANDLING OF USED CASSETTES. REVIEW OF TRACKING AND TRENDING DATA DID NOT REVEAL A TREND THAT NEEDED FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A FACILITY REPORTED A HEALTHCARE WORKER (HCW) CAME IN CONTACT WITH HYDROGEN PEROXIDE WHILE TOUCHING A USED CASSETTE FROM A STERRAD® 100NX. THE HCW WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AND EXPERIENCED "WHITE STAINING AND ITCHINESS FOR APPROXIMATELY 24 HOURS." THE HCW FLUSHED HIS HAND WITH WATER. NO MEDICAL ATTENTION WAS SOUGHT OR RECEIVED. THE HCW IS REPORTED TO BE "100% OK." THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660118 STERRAD 100NX CASSETTE STERRAD 100NX STERILIZER MLR ADVANCED STERILIZATION PRODUCTS NA 14G028

    Patients

    Seq Age Sex Outcome Treatment
    1