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	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic regulator not dispensing gas at all.Details of procedure was not reported.There was no patient harm.Additional details has been requested and none received till date.Additional information received reporting that during vitrectomy surgery the ophthalmic regulator was not dispensing gas at all.The surgery was completed on the same day with alternative product.
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.There samples were received for testing (at the manufacturing facility) on this investigation.There was testing done at the manufacturing facility, which correlates to the customers reported issue.The regulator was received the regulator in good condition.The regulator was tested and found to have no flow.The regulator was disassembled and reassembled, where it was found to have a flow rate of 850 cc/min at 100psi.Airgas therapeutics noted that the specification is 2000-4000cc/min.When attempting to adjust the regulator into specified flow range were unsuccessful.The manufacturer attributed the issue to ¿faulty regulator.¿ 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 non-conformance-based review of the serial number was performed and a potential contributing factor to the reported complaint was identified.The complaint was determined to not be relevant to this investigation.A review for complaints reported against this serial number was performed.The supplier also conducted a manufacturing review.However, no manufacturing issues were opened.The lot number was also reviewed by the supplier.Four complaints were previously opened against this lot were opened to address flow issues.Two complaints were opened to address issues.Overall, thirty-five (35) complaints have been opened since the beginning of 2017.All of those were related to regulator issues.Based on the information obtained, the root cause of the reported event is correlated 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: 19087857
• Report Number: 2518435-2024-00008
• Device Sequence Number: 18055180
• 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): 07/09/2024

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: 313711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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