BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 19991189 · Received August 15, 2024

    Report

    Report Number
    2518435-2024-00019
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 16, 2024
    Report Date
    November 4, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE DIRECTIONS FOR USE SECTION OF THE PAMPHLET SUPPLIED STATES "IF THE PRESSURE OF THE GAS FROM THE REGULATOR IS NOT SUFFICIENT TO PASSIVELY DISPLACE THE SYRINGE PLUNGER, GENTLY PULL BACK ON THE PLUNGER TO ASSIST FILLING THE SYRINGE WITH GAS." AIRGAS NOTES THAT A SITUATION WHERE THE GAS DOES NOT FILL THE SYRINGE WITHOUT MANUAL AID IS NOT A FAILURE OF THE REGULATOR. A NON-CONFORMANCE-BASED REVIEW OF THE LOT NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED. TWO (2) POTENTIALLY RELEVANT COMPLAINTS WERE FOUND AND REVIEWED AS PART OF THIS COMPLAINT. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC REGULATOR DID NOT FUNCTION AS EXPECTED WHEN DRAWING UP THE GAS INTO THE SYRINGE DURING VITRECTOMY WITH RETINAL DETACHMENT SURGERY. IT WAS ALSO REPORTED THAT WHEN THE SURGEON USED THE GASES, COULD NOT PUSH THE GAS IN TO THE SMALL VOLUME SYRINGE AND WHEN USED A LARGER VOLUME SYRINGE IT WAS VERY SLOW TO FILL BUT COULD BE IMPROVED BY BREAKING THE SEAL/PULLING BACK ON THE PLUNGER. THE SURGERY WAS COMPLETED ON THE SAME DAY WHEN OLD REGULATORS PUT ON THE TANK, THE PROBLEM WAS GREATLY IMPROVED ON ALL SIZE SYRINGES. THE PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684005 ISPAN GAS TANK REGULATOR REGULATOR, PRESSURE, GAS CYLINDER CAN AIRGAS THERAPEUTICS LLC NA 229210 00380657973033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown