BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 19357656 · Received May 21, 2024

    Report

    Report Number
    2518435-2024-00013
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Report Date
    September 27, 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
    MN, 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

    A REGULATOR WAS RETURNED ON THIS INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED. A CHECK OF THE COMPLAINT RECORDS SHOWED ONE OTHER COMPLAINT AGAINST LOT. THEREFORE, THERE ARE POTENTIAL CONTRIBUTING FACTOR(S) IDENTIFIED. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT WAS PERFORMED. THESE COMPLAINTS WERE DETERMINED TO NOT BE RELEVANT TO THIS INVESTIGATION. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. TWO REGULATORS WERE RECEIVED IN GOOD CONDITION AND TESTED FOR FLOW. ONE REGULATOR HAD NO FLOW AND COULD NOT BE ADJUSTED. THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE CAN BE ATTRIBUTED TO FAULTY REGULATORS. 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

    CORRECTED INFORMATION PROVIDED IN SECTIONS D.4. AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WAS SLOW TO DISPENSE GAS BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516525 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 224210 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown