BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 17755208 · Received September 15, 2023

    Report

    Report Number
    2518435-2023-00034
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Report Date
    December 12, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657970056
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS H.6. AND H.10. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER¿S REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. A CHECK OF THE BATCH PRODUCTION RECORD COULD NOT BE DONE BECAUSE NO LOT NUMBER WAS REPORTED. A CHECK OF COMPLAINT RECORDS FOR THE LOT COULD NOT BE DONE BECAUSE NO LOT NUMBER WAS REPORTED. A CHECK OF CONFIRMED COMPLAINTS FOR LOW PRESSURE OR EMPTY TANKS OF THIS TYPE SHOWED SEVEN SINCE THE BEGINNING OF 2016. NO SAMPLE WAS RETURNED FOR EVALUATION. BASED UPON THE INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    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 · 0

    A CUSTOMER REPORTED THAT THE AN OPHTHALMIC GAS CYLINDER WAS LEFT UNPLUGGED AND SOMETIMES THERE WAS NOT ENOUGH GAS WHEN USING IT. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295715 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657970056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown