BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14251256 · Received April 29, 2022

    Report

    Report Number
    1610287-2022-00024
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 30, 2022
    Report Date
    December 15, 2022
    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 WAS PROVIDED IN SECTIONS H.6 AND H.10. THE PERFLUOROPROPANE (C3F8) GAS TANK WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE BATCH PRODUCTION RECORD FOR LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST THE LOT NUMBER. A REVIEW OF CONFIRMED COMPLAINTS FOR PATIENTS THAT HAVE EXPERIENCED RETINAL DETACHMENT, CATARACTS, BLURRED VISION, OR DARK SHADOWS SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2015. AN ANALYSIS OF THE RETAIN SAMPLES OF LOT NUMBERS SHOWED THAT THE PRODUCT WAS PERFLUOROPROPANE (PFP) AND MEET ALL RELEASE CRITERIA. THE PROCEDURE DOES NOT COMPLY WITH THE DIRECTIONS FOR USE (DFU). THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE 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

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTION B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT IN THE CLINICAL TRIAL OF EVALUATING THE SAFETY OF AN OPHTHALMIC GAS DURING INTRAVITREAL INJECTION A PATIENT EXPERIENCED RHEGMATOGENOUS RETINAL DETACHMENT, CATARACT DEVELOPMENT, BLURRED VISION WITH DARK SHADOW FLOATING IN THEIR RIGHT EYE, THE CONJUNCTIVA OF THE RIGHT EYE WAS SLIGHTLY CONGESTED, AMETROPIA AND PATIENT UNDERWENT EXTRA SCLERAL PRESSURE OF RIGHT EYE, PHACOEMULSIFICATION, INTRAOCULAR LENS IMPLANTATION, VITREOUS CAVITY INJECTION, VITRECTOMY, VITREOUS PUNCTURE, DRUG INJECTION, MEMBRANE STRIPPING BEFORE REPAIR OF COMPLEX RETINAL DETACHMENT, RETINAL LASER PHOTOCOAGULATION AND INTERNAL PRESSURE REPAIR OF RETINAL DETACHMENT (RIGHT EYE). THE PATIENT WAS GIVEN WITH AMINOGLYCOSIDE ANTIBIOTIC OINTMENT, CORTICOSTEROIDS EYE DROPS, ANTICHOLINERGIC EYE GEL, QUINOLONE ANTIBIOTICS EYE DROPS, AMINOGLYCOSIDE ANTIBIOTIC INJECTION, ANTIMUSCARINIC EYE DROPS, CORTICOSTEROIDS SUSPENSION EYE DROPS. THE PATIENT WAS GENERALLY IN GOOD CONDITION, DID NOT COMPLAIN OF DISCOMFORT, AND THE DRESSING WAS CLEAN AND DISCHARGED WITH MEDICINE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CLARIFYING THE SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114635 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 121407 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention| O