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	07/03/2023
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 before a vitreo-retinal surgery an ophthalmic regulator did not dispense gas.Procedure was completed on the same day with another regulator.There was no patient harm.
Additional Manufacturer Narrative
Corrected information provided in sections d.2a, d.2b and g.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
There were three (3) regulators associated with this reported event.However, a single lot number will serve for one (1) of the regulators in this investigation.A check of the batch production record for this lot showed no unusual manufacturing issues.A check of the complaint records showed seven other complaints against this lot.A check of confirmed complaints for regulators showed 29 complaints since the beginning of 2016.This product is not a serviceable item but was returned for testing.One regulator for this lot was received in poor condition, there were ridge marks on the outlet.The regulator was tested and found to have flow within specification.However, it did express dead end pressure creep.Flow rate at 100psi must be between 2000 and 4000 cc/min.When the flow is blocked, the pressure in the line post regulator must be less than 10psi.When regulator for this lot was tested (for pressure regulation) the unit went above 10psi and therefore failed for high dead-end pressure.Although there was flow, the unit does not meet specifications.The root cause of the reported event is determined to be a faulty regulator.However, how or why this regulator became non-conforming cannot be conclusively determined.The root cause of the reported event is determined to be a faulty regulator.However, how or why this regulator became non-conforming cannot be conclusively determined.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: 17423460
• Report Number: 2518435-2023-00022
• Device Sequence Number: 17655920
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023
• 2 Devices were Involved in the Event: 1 2

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: 112607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 10/04/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/30/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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