BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14513898 · Received May 26, 2022

    Report

    Report Number
    1610287-2022-00039
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    January 12, 2022
    Report Date
    September 19, 2024
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971022
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    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

    ADDITIONAL INFORMATION PROVIDED IN SECTION H.6 AND H.10. THE C3F8 [PERFLUOROPROPANE (PFP)] GAS TANK WAS NOT RETURNED FOR EVALUATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SEVEN OTHER COMPLAINTS AGAINST LOTS. A CHECK OF CONFIRMED COMPLAINTS FOR CORNEAL EPITHELIAL INJURY, CORNEAL EDEMA, OR OCULAR HYPERTENSION SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2015. NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FOR LOTS, SHOWED THAT THE PRODUCT WAS PERFLUOROPROPANE (PFP) AND MET ALL RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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 WAS PROVIDED IN SECTIONS B.2, B.5., AND H.11. UPON FURTHER INFORMATION, REPORTED ADVERSE EVENT MEDICAL AND SURGICAL INTERVENTION WAS INCORRECTLY REPORTED IN INITIAL REPORT. NO FURTHER REPORT WILL BE SUBMITTED UNDER THIS MFG 1610287-2022-00039 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS NO SAMPLE RETURNED FOR TESTING. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED. 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 THIS LOT, SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED. A CHECK OF THE COMPLAINT RECORDS SHOWED EIGHT OTHER COMPLAINTS AGAINST THIS LOT AND WERE FOUND TO BE POTENTIALLY RELEVANT AS THESE RECORDS WERE ALSO REPORTED AS PART OF CLINICAL STUDIES. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED. 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 CLINICAL STUDY REPORT STATING THAT AFTER USING THE PERFLUOROPROPANE GAS THE PATIENT WAS EXPERIENCED WITH CORNEAL EDEMA IN LEFT EYE. MEDICAL TREATMENT WAS PROVIDED AND SYMPTOMS WERE RESOLVED.

    Description of Event or Problem · 0

    EVENT REPORTED IN INITIAL REPORT P-ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS INCORRECTLY SUBMITTED. NO EXTRA MEDICAL/SURGICAL INTERVENTION WAS TAKEN FOR THE CORNEAL EDEMA IN THIS CASE. THIS WILL NOT BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388174 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O