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	06/04/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A nurse reported that no gas came out of regulator during surgery.The surgery was completed on the same day.There was no patient harm.Details of surgery was not reported.
Additional Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A regulator was returned on this investigation.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 check of the batch production record for this lot showed no unusual manufacturing issues.A total of 77 regulators were released in this lot.A review for complaints reported against this lot was performed.A potentially relevant complaint was found and reviewed as part of this complaint.Airgas team performed a check of confirmed complaints for regulators with low or no flow showed 39 complaints since the beginning of 2017.One regulator was received for this investigation, in good condition.The regulator was tested and passed for flow with 3700 cc/min (specification is 2000-4000 cc/min).However, the regulator failed for dead end pressure at 320 pounds per square inch (psi), it was allowing 10.50 psi and rising to flow through (specification is <10 psi).How or why the regulators became nonconforming is inconclusive based on the information obtained at this time.A non conformance investigation was opened to address the issue.Based on the information obtained, the root cause of the ispan regulator not releasing gas can be attributed to faulty regulators.How or why the regulators became nonconforming is inconclusive based on 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).

• 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: 19660798
• Report Number: 2518435-2024-00018
• Device Sequence Number: 20444583
• Product Code: CAN
• UDI-Device Identifier: 00380657973033
• UDI-Public: (01)00380657973033(17)281231(11)231228(10)334803(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2024

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: 334803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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