BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 11862984 · Received May 21, 2021

    Report

    Report Number
    1610287-2021-00010
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 1, 2021
    Report Date
    August 17, 2021
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    UDI-DI
    00380657970056
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SULFUR HEXAFLUORIDE (SF6) GAS SAMPLE WAS NOT RETURNED FOR TESTING. A RETAINED SAMPLE FOR LOT PROVIDED WAS ANALYZED BY GAS CHROMATOGRAPH (GC). THE GC ANALYSIS CONFIRMED THE GAS TO BE SULFUR HEXAFLUORIDE WITH AN AIR CONCENTRATION OF NOT MORE THAN 100PPM AND WITH NO UNUSUAL GC PEAKS, MEETING THE RELEASE SPECIFICATION. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE OPHTHALMIC GAS CONTRIBUTED TO THE EVENT REPORTED. THE SF6 GAS WAS MANUFACTURED ON APRIL 23, 2021. A REVIEW OF THE BATCH PRODUCTION RECORD FOR LOT PROVIDED WAS PERFORMED AND CONFIRMED THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF COMPLAINTS FOR THE LAST 12 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS SF6 GAS. A REVIEW OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST LOT PROVIDED. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT FOLLOWING A VITRECTOMY PROCEDURE TWO PATIENT'S EXPERIENCED RETINAL DAMAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THIS REPORT REPRESENTS PATIENT ONE OF TWO FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759733 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA 011401 00380657970056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other