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	Insufficient Information (4580)
Date of Event	07/16/2024
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 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.
Additional Manufacturer Narrative
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).

• 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: 19991189
• Report Number: 2518435-2024-00019
• Device Sequence Number: 8543769
• Product Code: CAN
• UDI-Device Identifier: 00380657973033
• UDI-Public: (01)00380657973033(17)271019(11)221019(10)229210(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 229210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 10/19/2022
• 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