BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 19349867 · Received May 20, 2024

    Report

    Report Number
    2518435-2024-00012
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 21, 2024
    Report Date
    September 28, 2024
    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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WERE NO SAMPLES RETURNED ON THIS INVESTIGATION FROM THE CUSTOMER. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE CANNOT BE DETERMINED. 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 NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND SHOWED INVESTIGATIONS A LIKE. A CHECK OF THE COMPLAINT RECORDS SHOWED FOUR OTHER COMPLAINTS AGAINST THIS LOT WITH POTENTIAL CONTRIBUTING FACTOR(S) IDENTIFIED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, A NONCONFORMANCE INVESTIGATION WAS OPENED TO ADDRESS THE ISSUE. 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 BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC GAS REGULATOR WAS UNABLE TO RELEASE GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147453 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 313711 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown