BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1623216 · Received February 24, 2010

    Report

    Report Number
    2518435-2010-00002
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Report Date
    February 1, 2010
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT RETURNED FOR EVALUATION WAS EMPTY. THE RETAINED CYLINDER FOR THE MASTER LOT (825509) USED TO TRANSFILL LOT 825509 WAS ANALYZED. ALL RESULTS WERE FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED NO PROCESS OR ANALYSIS ISSUES. THIS REPORT MAILED IN TO THE FDA ON: 02/24/2010.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT INTRAOCULAR SF6 DID NOT LAST AS EXPECTED ON ONE PATIENT. THE PATIENT REQUIRED A SECOND PROCEDURE AS A RESULT OF THE BUBBLE NOT LASTING LONG ENOUGH. NO PATIENT IDENTIFIERS WERE PROVIDED. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS PRODUCT CODE LPO/ INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 125 G 825509

    Patients

    Seq Age Sex Outcome Treatment
    1