BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 17362354 · Received July 20, 2023

    Report

    Report Number
    2518435-2023-00020
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 27, 2023
    Report Date
    November 15, 2023
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS AGAINST THIS TYPE OF REGULATOR FOR FLOW ISSUES SHOWED 24 COMPLAINTS SINCE THE BEGINNING OF 2016. THE REGULATOR THIS LOT WAS RECEIVED IN GOOD CONDITION. THE REGULATOR WAS TESTED AND FOUND TO HAVE VERY LOW FLOW AT 100PSI. THE REGULATOR WAS DISASSEMBLED AND INSPECTED, AND IT WAS NOTICED THAT THE PLUNGER HAD BECOME STUCK IN POSITION. THE PLUNGER WAS RELEASED FROM THE STUCK POSITION AND THE REGULATOR WAS REASSEMBLED AND RETESTED. THE REGULATOR PASSED ALL CRITERIA. THERE IS NO INDICATION AS TO WHY OR HOW THE PLUNGER GOT STUCK FOR THIS REGULATOR. THE ROOT CAUSE OF THE REPORTED ¿PLUNGER INSIDE THE REGULATOR HAD BECOME STUCK IN POSITION CAUSING LOW FLOW¿ CANNOT BE CONCLUSIVELY DETERMINED. BASED UPON THE INFORMATION OBTAINED, AT THIS TIME. 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 AN OPHTHALMIC REGULATOR WOULD NOT WORK AND IT WAS NOT DISPENSED THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED THAT SURGERY WAS COMPLETED BY USING THE ALTERNATIVE REGULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803430 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 301022 00380657973033
    734486 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 301022 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown