BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 14679394 · Received June 13, 2022

    Report

    Report Number
    1610287-2022-00043
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 19, 2022
    Report Date
    October 21, 2022
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657973033
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    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. WITH THE INFORMATION PROVIDED, THE CUSTOMERS¿ REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT, SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED (B)(4) COMPLAINTS AGAINST THE SAME LOT NUMBER. A CHECK OF CONFIRMED COMPLAINTS SHOWED (B)(4) SIMILAR COMPLAINTS. THERE WAS NO SAMPLE RETURNED FOR THIS INVESTIGATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. BASED UPON THE INFORMATION OBTAINED, 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).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT DURING A VITRECTOMY PROCEDURE AN OPHTHALMIC REGULATOR KNOB WAS FALLEN OFF AND IT COULD NOT DISPENSE THE PERFLUROPROPANE (C3F8). THE PROCEDURE WAS COMPLETED USING SILICONE OIL FOR THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426998 ISPAN GAS TANK REGULATOR INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 104323 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown