BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM

    MDR report key: 7300749 · Received February 27, 2018

    Report

    Report Number
    2083544-2018-00004
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 27, 2018
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOAM IS INSERTED IN THE CASSETTE AS A CONVENIENCE FOR THE LAB TECHNICIANS. DUE TO THE NATURE OF THE FOAM, THE FOAM MAY DETACH FROM THE CASSETTE LID. AS SUCH SAKURA HAD ADDED A WARNING LABEL TO EACH BOX AS AN ADDITIONAL SAFETY FACTOR TO FURTHER WARN THE USER TO ENSURE THE FOAM IS IN PLACE BEFORE USE. FURTHERMORE, IT IS REQUIRED BY THE OPERATING MANUAL, AND TRAINING PROVIDED TO THE TECHNICIANS TO PLACE THE TISSUE ON THE FOAM IN ORDER TO ENSURE THE PRESENCE OF THE FOAM. TECHNICIANS ARE AWARE OF THIS AS THIS INFORMATION IS PRESENT IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, SAKURA FINETEK USA, INC. WAS NOTIFIED THAT A USER LOST A PATIENT'S SPECIMEN (CARDIAC BIOPSY) ON (B)(6) 2018. A GROSSING TECHNICIAN USED A SAKURA'S 13X13 BIOPSY PARAFORM INSERT (PRODUCT CODE 7019) WITHOUT NOTICING THE SPONGE IN THE LID WAS MISSING. THE SPECIMEN WAS LOST DURING PROCESSING ON A PELORIS PROCESSING INSTRUMENT BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142053 TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM BIOPSY CASSETTE IDZ SAKURA FINETEK USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other