BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC

    MDR report key: 15836 · Received September 6, 1994

    Report

    Report Number
    MW1003261
    Event Type
    Malfunction
    Date Received
    September 6, 1994
    Report Date
    September 2, 1994
    Manufacturer
    BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PARTIAL FAILURE OF THE POWER SUPPLY THAT HEATS THE NEEDLE TO STERILIZE IT. THE ALARM SYSTEM DID NOT WORK PROBABLY BECAUSE THERE WAS ENOUGH CURRENT TO PREVENT IT FROM ALARMING. AFTER A MASSIVE NUMBER OF POSITIVE CULTURES (OVER 100), FOR ACID FAST BACILLI, A TECHNICIAN STOOD IN FRONT OF THE DEVICE AND WATCHED AS IT PROCESSED THE CULTURES. THE TECHNICIAN DISCOVERED THAT THE WIRE THAT WAS SUPPOSED TO STERILIZE THE NEEDLE DID NOT GET RED AS IT SHOULD HAVE AND TOUCHING THE AREA, FOUND THAT IT WAS NOT HOT. THE RPTR STATED THAT CHECKING FOR THE GLOWING WIRE WAS NOT SOMETHING THAT A PERSON WOULD NORMALLY DO TO SEE IF THE DEVICE WAS PERFORMING PROPERLY. TEN PTS WHO HAD BEEN POSITIVE WERE ENTERED INTO THE COMPUTER; THE RPTR KNEW OF TWO THAT HAD STARTED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC INSTRUMENT FOR MICROBACTERIAL CULTURES JTA BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 460

    Patients

    Seq Age Sex Outcome Treatment
    1 *