BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 16085500 · Received January 3, 2023

    Report

    Report Number
    2518435-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Report Date
    May 5, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CHECK OF THE BATCH PRODUCTION RECORD FOR LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST LOT. A CHECK OF CONFIRMED COMPLAINTS OF THIS TYPE, SHOWED THERE HAVE BEEN EIGHT SINCE THE BEGINNING OF 2015. ONE CYLINDER OF THIS LOT WAS IN GOOD CONDITION AS RECEIVED. THE CYLINDER WAS WEIGHED AND FOUND TO BE EMPTY. BASED UPON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. AT THIS TIME, 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).

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT REGULATOR WAS MISSING AN O-RING AND THAT IS WHY THE GAS HAD LEAKED FROM THE SULPHUR HEXAFLUORIDE (SF6) CYLINDER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING SURGERY WHEN OPENED A NEW CYLINDER FOR SULPHUR HEXAFLUORIDE(SF6) DID SHOW THAT THE CYLINDER IS FULL AND TOOK ONLY 10 CC FROM IT, THEN THE REGULATOR WENT TO THE EMPTY SIGN RIGHT AWAY. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502320 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 106918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ISPAN GAS TANK REGULATOR