BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 17650876 · Received August 30, 2023

    Report

    Report Number
    2518435-2023-00029
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    December 12, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    CAN
    UDI-DI
    00380657973033
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED ONE OTHER COMPLAINT AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 25 COMPLAINTS SINCE THE BEGINNING OF 2016. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. THERE WAS NO SAMPLE RETURNED FOR THIS INVESTIGATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. BASED UPON THE INFORMATION OBTAINED, 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

    ADDITIONAL INFORMATION RECEIVED SCHEDULED PROCEDURE WAS CATARACT AND VITRECTOMY COMBINATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT OPHTHALMIC GAS TANK VALVE NOT MEASURING THE VOLUME CONTAINED AND NOT RELEASING THE GAS FOR USE, EVEN WITH A FULL TORPEDO. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302591 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 105514 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown