BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREPSTAIN SLIDE PROCESSOR

    MDR report key: 2011759 · Received March 4, 2011

    Report

    Report Number
    1062336-2011-00002
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BD DIAGNOSTIC - TRIPATH
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER DISCUSSION WITH THE SITE, THE USER WAS INSTRUCTED TO TROUBLESHOOT CLOGS BY USING A STYLUS TO MANUALLY UNCLOG THE BUNDLE AND SOAKING CLOGGED TIPS IN WARM SOAPY WATER. IT WAS ALSO RECOMMENDED TO THE SITE THAT THEY USE CONTRAD SOLUTION ON A REGULAR BASIS; CURRENTLY, THE USE BLEACH AND WATER. THE DECISION TO REPORT THIS EVENT IS BASED UPON THE NEED FOR THE USER TO OBTAIN MEDICAL ATTENTION. THE USER RECEIVED A TETANUS SHOT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT SHE INJURED HER THUMB WHILE CLEANING THE STAINING BUNDLES ON THE PREPSTAIN SLIDE PROCESSOR. THE CUSTOMER HAD A CLOG IN THE ASPIRATION TIP ON A BUNDLE THAT SHE COULD NOT CLEAR. THE BUNDLE WAS REMOVED FROM THE PREPSTAIN WITH A WRENCH. IN AN ATTEMPT TO CLEAR WITH A STYLUS, SHE STUCK HER THUMB WITH THE STYLUS AND HAD TO SEEK EMERGENCY TREATMENT. THE CUSTOMER INCURRED A MINOR INJURY AND RECEIVED A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPSTAIN SLIDE PROCESSOR NONE MKQ BD DIAGNOSTIC - TRIPATH TECAN AG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other