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

Catalog Number 8065797303

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

A customer reported that ophthalmic gas tank valve not measuring the volume contained and not releasing the gas for use, even with a full torpedo.The procedure details and patient impact were not reported.

Event Description

Additional information received scheduled procedure was cataract and vitrectomy combination.

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.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 serial number was performed.No similar complaints were reported for the product serial under investigation.Check of the batch production record for this lot showed no unusual manufacturing issues.A check of the complaint records showed six other complaints against this lot.A check of confirmed complaints for regulators with low or no flow showed 25 complaints since the beginning of 2016.The sample was not returned.Based upon the information provided, a root cause cannot be conclusively determined.Based upon the information provided, a root cause 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
• Type of Device: 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: 17806699
• MDR Text Key: 324116851
• Report Number: 2518435-2023-00037
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Catalogue Number: 8065797303
• Device Lot Number: 633525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1