BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFILLED FORMALIN CONTAINER

    MDR report key: 6854744 · Received September 11, 2017

    Report

    Report Number
    6854744
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 31, 2017
    Manufacturer
    PATH-TEC
    Product Code
    OHZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PREFILLED FORMALIN SPECIMEN CUPS WERE NOTED TO BE BROKEN WITHOUT ANY FORMALIN IN THE CUP. NO PATIENT SPECIMEN WAS PLACED IN THE CUP. NEW SPECIMEN CUP WAS RETRIEVED AND PROCESSED WITH NO PROBLEM. MANUFACTURER RESPONSE FOR SPECIMENT CONTAINER, 40ML PREFILLED FORMALIN CONTAINER (PER SITE REPORTER). REPORTED EQUIPMENT FAILURE TO (B)(4), ALONG WITH PICTURES. PATH TEC REPRESENTATIVE IS INVESTIGATING EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636552 PREFILLED FORMALIN CONTAINER URINE TRANSPORT KIT (EXCLUDES HIV TESTING) OHZ PATH-TEC

    Patients

    Seq Age Sex Outcome Treatment
    1