BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 20329755 · Received September 29, 2024

    Report

    Report Number
    2518435-2024-00022
    Event Type
    Malfunction
    Date Received
    September 29, 2024
    Report Date
    January 28, 2025
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657970025
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IS PROVIDED IN SECTION D.4. ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.11. THE SUSPECT PRODUCT COULD NOT BE DETERMINED BASED ON THE REPORTED EVENT. THEREFORE, THIS COMPLAINT WILL INCLUDE INVESTIGATION FOR THE GAS TANK AND INVOLVED REGULATOR. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. NO PHOTO(S) AND/OR VIDEO(S) WAS PROVIDED FOR EVALUATION BY THE REPORTER AND A SAMPLE OF THE GAS TANK AND REGULATOR WERE NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. TESTING COULD NOT BE PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 CHECK OF THE BATCH PRODUCTION RECORD FOR GAS TANK LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A NON-CONFORMANCE BASED REVIEW OF THE GAS TANK LOT NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. THE REGULATOR PART NUMBER AND LOT NUMBERS WEREN¿T PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A CHECK OF THE BATCH PRODUCTION RECORD COULD NOT BE PERFORMED BECAUSE NO LOT NUMBER FOR THE REGULATOR WAS REPORTED. A NON-CONFORMANCE BASED REVIEW OF THE REGULATOR LOT NUMBER COULD NOT BE PERFORMED BECAUSE NO LOT NUMBER WAS REPORTED. A REVIEW FOR COMPLAINTS REPORTED AGAINST GAS TANK LOT WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT LOT UNDER INVESTIGATION. A REVIEW FOR COMPLAINTS REPORTED AGAINST THE REGULATOR LOT NUMBER CANNOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION OBTAINED, 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).

    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

    A CUSTOMER REPORTED THAT DURING CALIBRATION, AN OPHTHALMIC GAS DID NOT COME OUT WHEN CONNECTED TO THE VALVE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040962 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 309403 00380657970025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown