BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 3190766 · Received June 24, 2013

    Report

    Report Number
    1610287-2013-00020
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 29, 2013
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. 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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    AN OFFICE MANAGER REPORTED THAT DURING A SURGICAL PROCEDURE, THE EXISTING GAS TANK WOULD NOT ALLOW FOR THE SYRINGE TO FILL. DURING THE PROCEDURE, IMMEDIATELY PRECEDING WHILE USING THE SAME REGULAR VALVE, THE VALVE WAS NOTED TO FUNCTION PROPERLY. THERE WAS AN APPROXIMATE 30 MINUTE DELAY IN STARTING THE PROCEDURE UNTIL THE SYRINGE COULD BE FILLED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286521 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ ALCON LABORATORIES INC. NA 231124

    Patients

    Seq Age Sex Outcome Treatment
    1