BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 19401126 · Received May 27, 2024

    Report

    Report Number
    2518435-2024-00015
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    April 24, 2024
    Report Date
    August 7, 2024
    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
    NC, US
    Reporter Occupation
    003

    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 PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THE REGULATOR WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A NON-CONFORMANCE-BASED REVIEW OF THE BATCH PRODUCTION RECORD FOR THIS LOT WAS PERFORMED AND SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW FOR COMPLAINTS FROM AIRGAS THERAPEUTICS REPORTED FOR A CLOG IN THE GAS REGULATOR SHOWED 14 OTHER COMPLAINTS AGAINST THIS LOT. IN ADDITION, A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 37 COMPLAINTS SINCE THE BEGINNING OF 2017. AS A RESULT, THE NON-CONFORMANCE REVIEW SHOWED THERE ARE POTENTIAL CONTRIBUTING FACTOR(S). THIS REGULATOR WAS RECEIVED, AND THE UNIT WAS PUT THROUGH FINAL INSPECTION AND TEST AND WAS FOUND TO BE IN GOOD CONDITION. SINCE THE UNIT MEETS ALL RELEASE CRITERIA, WITH NO IMPEDIMENT TO FLOW NOTED, THE CUSTOMER REPORTED EVENT COULD NOT BE REPLICATED. THE UNIT IS AVAILABLE FOR RETURN TO THE CUSTOMER FOR THIRTY DAYS FROM THE DATE OF THE REPORT. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. THE REGULATOR MET SPECIFICATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 CUSTOMER REPORTED THAT THE OPHTHALMIC CONSOLE GAS REGULATOR CLOGGED. THEY REMOVED THE REGULATOR AND UTILIZED A SECOND ONE FOR USE. THERE HAS BEEN NO PATIENT PRESENT DURING THE SETUP FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298801 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 711606 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown