BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX CASSETTE, GHS

    MDR report key: 10945921 · Received December 4, 2020

    Report

    Report Number
    2084725-2020-50292
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 17, 2020
    Report Date
    April 12, 2021
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    UDI-DI
    20705037014900
    PMA / PMN Number
    K071345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE BATCH RECORD, SUPPLIER PRODUCT EVALUATION, TRENDING ANALYSIS BY LOT NUMBER, AND SYSTEM RISK ANALYSIS (SRA). THE BATCH RECORD WAS NOT REVIEWED AS THE LOT NUMBER OF THE CASSETTE WAS NOT AVAILABLE. SUPPLIER PRODUCT EVALUATION WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED ISSUE IS USER ERROR. TRENDING ANALYSIS BY LOT NUMBER WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE SRA INDICATES THE RISK ASSOCIATED WITH IMPROPER HANDLING OF A CASSETTE IS "LOW." THE ISSUE HAS BEEN ATTRIBUTED TO USER ERROR AS THE HEALTHCARE WORKER (HCW) HANDLED A USED CASSETTE WITHOUT UTILIZING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE). AN ASP REPRESENTATIVE PROVIDED RE-TRAINING AND REMINDED THE CUSTOMER TO ALWAYS WEAR GLOVES WHEN HANDLING ANY PART OF THE STERRAD SYSTEM OR LOAD ITEMS THAT HAVE BEEN EXPOSED TO H202 INCLUDING NEW OR USED STERRAD CASSETTES. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SERIAL STERRAD® 100NX STERILIZER, # (B)(4). ASP COMPLAINT REF #: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) RECEIVED A SKIN REACTION AFTER REMOVING A STERRAD® 100NX CASSETTE FROM THEIR STERRAD® STERILIZER. SHE REPORTED WHILE REMOVING THE CASSETTE COLLECTION BOX, THE CASSETTE DID NOT FALL FLAT INTO THE BOX SO SHE TOUCHED THE CASSETTE TO HELP PLACE IT PROPERLY INTO THE BOX. SHE WAS NOT WEARING GLOVES AND HER LEFT INDEX FINGER TURNED WHITE. SHE WASHED WITH WATER FOR A FEW MINUTES AND APPLIED NEOSPORIN AND A BAND-AID. SHE REPORTED SHE DID NOT NEED TO GO TO THE EMERGENCY ROOM AND THE WHITE SPOT WAS COMPLETELY GONE LATER THAT NIGHT. LASTLY, THE HCW REPORTED SHE WAS ¿FINE¿. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415142 STERRAD 100NX CASSETTE, GHS STERRAD® 100NX STERILIZER MLR ADVANCED STERILIZATION PRODUCTS UNK 20705037014900

    Patients

    Seq Age Sex Outcome Treatment
    1