MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN GAS TANK REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Catalog Number	8065797303
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported during a vit retinal surgery that when the user attempted to dispense the gas it would not come out at all from an ophthalmic regulator.The procedure was paused and used another free-standing regulator to complete.No patient harm or impact as a new regulator was used to complete the procedure.
Additional Manufacturer Narrative
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
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, one regulator was returned for testing on this investigation.A check of the batch production record for this lot showed no unusual manufacturing issues.A check of the complaint records showed two other complaints against this lot.A check of confirmed complaints for regulators with low or no flow showed 26 complaints since the beginning of 2016.The regulator was received for testing on for this investigation.It was returned in good condition and tested.The regulator was put through normal release testing for the regulator component using house nitrogen gas.To meet specifications, flow rate of gas at 100psi through the regulator must be between 2000 and 4000 cc/min.The flow rate was low (~500 cc/min).The regulator failed flow specification and could not be adjusted.The reported event is attributed to an inconsistent regulator flow function due to a faulty regulator.How or why this regulator became non-conforming cannot be conclusively determined, based upon the information provided at this time.The root cause of the reported event is attributed to a faulty regulator.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).

• Brand Name: ISPAN GAS TANK REGULATOR
• Common Device Name: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17762242
• Report Number: 2518435-2023-00035
• Device Sequence Number: 20626131
• Product Code: CAN
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: 312908
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/17/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown