BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIK PAK

    MDR report key: 2736711 · Received August 31, 2012

    Report

    Report Number
    1610287-2012-00108
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED THAT THE CANNULA DISLODGED INTO THE PT'S EYE AT AN ANGLE DURING A PROCEDURE. THE SURGEON STARTED WITH LIGHT PRESSURE AND WHEN HE EXERTED A LITTLE MORE PRESSURE, THE CANNULA POPPED OFF. THE CANNULA WAS REMOVED FROM THE EYE AND FELL BELOW AND STERILE FIELD, THEREFORE, ANOTHER 30 GAUGE IRRIGATING CANNULA FROM THE PACK WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIK PAK PIK PAK LRO ALCON - FORT WORTH / ALCON LABORATORIES, INC. 8065XXXXPP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IRRIGATING 30 GAUGE 4MM BEND TIP