BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 17806699 · Received September 25, 2023

    Report

    Report Number
    2518435-2023-00037
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Report Date
    December 20, 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 PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SIX OTHER COMPLAINTS 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. BASED UPON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. BASED UPON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE CONCLUSIVELY 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).

    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).

    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
    1810223 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 633525 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown