BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 2094623 · Received May 4, 2011

    Report

    Report Number
    1610287-2011-00048
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CYLINDER 27 OF LOT 024207 WAS RECEIVED FOR EVALUATION. REVIEW OF LOT 024207 WAS COMPLETED AND THERE ARE NO SIMILAR REPORTS FOR THIS LOT. WHEN RECEIVED THE ARROW ON THE VALVE LABEL WAS NOT POINTING TO THE OUTLET AND IT COULD NOT BE TURNED BY HAND. THE VALVE WAS STUCK IN THE FULLY OPEN POSITION. ONCE THE VALVE WAS LOOSENED, IT COULD BE TURNED BY HAND. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 04/05/2011, 04/29/2011, AND 05/02/2011; VIA MAIL ON 04/05/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE BLACK KNOB ON THE TANK WOULD NOT TURN AND IT LOOKED SLIGHTLY CROOKED. SHE STATED THEY SWITCHED FROM THIS PRODUCT TO CF6 GAS AND THERE WAS A DELAY IN THE PROCEDURE OF AT LEAST 15 MINUTES. AT THIS TIME PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES, INC NA 024207

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR