BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 16377744 · Received February 15, 2023

    Report

    Report Number
    2518435-2023-00003
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Report Date
    May 15, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 2023-03903

    Additional Manufacturer Narrative · 0

    A CHECK OF THE COMPLAINT RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A CHECK OF CONFIRMED COMPLAINTS FOR SF6 EYE GAS NOT STAYING IN THE PATIENT'S EYE FOR AS LONG AS EXPECTED SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2016. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. BASED UPON THE INFORMATION PROVIDED AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING A SURGERY OPHTHALMIC GAS DOES NOT LAST AS LONG AS IT USED TO IN THE PATIENTS EYE. BOTH THE REGULATOR AND OPHTHALMIC GAS TANK WERE EXCHANGED AND STILL ISSUE HAD NOT RESOLVED. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126711 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657970056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown