BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROCOTTS METHENAMINE SILVER STAIN

    MDR report key: 359816 · Received November 5, 2001

    Report

    Report Number
    359816
    Event Type
    Injury
    Date Received
    November 5, 2001
    Date of Event
    June 21, 2001
    Report Date
    November 5, 2001
    Manufacturer
    RICHARD-ALLAN SCIENTIFIC
    Product Code
    HYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BRONCHIAL FLUID SENT TO CYTOLOGY WAS CONTAMINATED DURING PROCESSING WITH FUNGAL ELEMENTS. PT RESULTS WERE RELEASED: STATING "POSITIVE FOR FUNGUS". THE NEXT DAY, ANOTHER SPECIMEN HAD THE SAME FUNGAL ELEMENTS, THE SLIDES WERE COMPARED AND SIMILARITIES LEAD TO THE CONCLUSION THAT THIS WAS A CONTAMINANT. THROUGH THE NEXT SEVERAL WEEKS, A THOROUGH INVESTIGATION AS TO THE SOURCE OF THE CONTAMINANT WAS CONDUCTED. EVENTUALLY IT WAS DISCOVERED THAT A PURCHASED STAIN PRODUCT WAS BEING DELIVERED TO HOSPITAL ALREADY CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49391 GROCOTTS METHENAMINE SILVER STAIN FAST GREEN STAIN USED TO PROCESS CYTOLOGY SPECIMENS HYC RICHARD-ALLAN SCIENTIFIC * 1E31A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening GROCOTTS METHENAMINE SILVER STAIN