BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 12263768 · Received August 2, 2021

    Report

    Report Number
    1610287-2021-00017
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Report Date
    October 29, 2021
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    UDI-DI
    00380657970025
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CONTRACT MANUFACTURER EVALUATION, A CHECK OF THE BATCH PRODUCTION RECORD FOR THE REPORTED LOT NUMBER WAS PERFORMED. WHICH CONFIRMED, THAT THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. ADDITIONALLY, A CHECK OF THE COMPLAINT RECORDS SHOWED, NO OTHER COMPLAINTS AGAINST THE REPORTED LOT. THE REPORTED OPHTHALMIC GAS WAS UNABLE TO BE EVALUATED, BECAUSE A SAMPLE WAS NOT RETURNED. AS NO SAMPLE WAS RETURNED FOR EVALUATION. AND WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THEREFORE, NO FURTHER ACTIONS CAN BE PURSUED AT THIS TIME. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT. AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TREND AND TAKE FURTHER ACTION, AS APPROPRIATE. AT A MINIMUM, THIS WILL INCLUDE COMPLETING REVIEWS OF COMPLAINT CLASS REPORT LEVELS ON A MONTHLY BASIS BY THE PRODUCT TEAM. 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 HEALTH PROFESSIONAL REPORTED THAT AN OPHTHALMIC GAS BUBBLE DID NOT EXPAND WHILE INSIDE OF THE PATIENT¿S RIGHT EYE FOR OVER 1-2 WEEKS RATHER, THE BUBBLE JUST DISSIPATED OVER A FEW DAYS WITH NO EXPANSION. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156201 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA 905911 00380657970025

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ISPAN GAS TANK REGULATOR| REGULATOR-NEW DESIGN,