BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCHMARK SPECIAL STAINS SYSTEM

    MDR report key: 12746472 · Received November 3, 2021

    Report

    Report Number
    2028492-2021-00008
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 1, 2020
    Report Date
    December 24, 2021
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED TO EVALUATE THE CUSTOMER ISSUE. ALTHOUGH THE ACTUAL LEAK WAS NEVER SEEN, IT MOST LIKELY ORIGINATED FROM A BENCHMARK SPECIAL STAINS CARBOY SPIGOT THAT WAS NOT SHUT OFF PROPERLY. THERE WAS NO EVIDENCE OF THE SOURCE OF LEAK AND IT DOES NOT SEEM LIKELY THAT THE ALLEGED DEVICE CAUSED OR CONTRIBUTED TO THE TECHNICIAN'S INJURY. THERE IS NO EVIDENCE THE ADVERSE EVENT WAS CAUSED BY A ROCHE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    FULL NAME - (B)(6). A CUSTOMER IN (B)(6) REPORTED THAT A LAB TECHNICIAN SLIPPED AND INJURED THEIR SHOULDER AND HAD TO UNDERGO INTERVENTIONAL SURGERY AS A RESULT OF A LEAKAGE FROM SPIGOT THAT THE USER FORGOT TO PROPERLY CLOSE FROM A BENCHMARK SPECIAL STAINS STAINER MODULE. PER CUSTOMER SITE'S INTERNAL INVESTIGATION, THIS WAS A HUMAN ERROR. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT A LAB TECHNICIAN SLIPPED AND INJURED THEIR SHOULDER AND HAD TO UNDERGO INTERVENTIONAL SURGERY AS A RESULT OF A LEAKAGE FROM SPIGOT THAT THE USER FORGOT TO PROPERLY CLOSE FROM A BENCHMARK SPECIAL STAINS STAINER MODULE. PER ADDITIONAL INFORMATION, THERE WAS LEAKAGE FROM A STORAGE CONTAINER OF BULK REAGENTS AS A RESULT OF THE SPIGOT/TAP NOT CLOSED OR OVERTURNED INAPPROPRIATELY. PER THE OPERATOR'S MANUAL - PLACE MATS AROUND THE INSTRUMENT TO AVOID RISK OF SLIPPING IN THE EVENT OF REAGENT SPILLS OR LEAKS. PER CUSTOMER SITE'S INTERNAL INVESTIGATION, THIS WAS A HUMAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647479 BENCHMARK SPECIAL STAINS SYSTEM SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O