BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 14470977 · Received May 23, 2022

    Report

    Report Number
    1610287-2022-00031
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 5, 2022
    Report Date
    August 18, 2022
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657973033
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REGULATOR WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE BATCH PRODUCTION RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE EXPIRATION DATE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED SOME COMPLAINTS. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. 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 HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE A VITREO RETINAL PROCEDURE THE OPHTHALMIC GAS WAS NOT RELEASED FROM THE TANK. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT CONTACT OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543208 ISPAN GAS TANK REGULATOR INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown