MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN SULFUR HEXAFLUORIDE (SF6) GAS; INTRAOCULAR GAS

Catalog Number 8065797002

Device Problem Gas Output Problem (1266)

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 healthcare professional reported that the issue of the gas not decanting properly has been for an extended period of time with numerous patients.All surgeries were able to be completed without incident, either by waiting for a very long time for the sf6 to flow, or by surgeon changing to different gas.All procedures were retinal vitrectomies.No system used to give message or warning.No patient harm or surgical complication, simply delayed procedure time.

Manufacturer Narrative

This investigation will serve for the suspect regulator reported.However, this regulator was not returned for testing on this investigation.A check of the batch production record for the regulator could not be performed because a valid lot number was not reported.The manufacturing date could not be determined.A check of the complaint records for the regulator lot could not be performed because a valid lot number was not provided.A check of confirmed complaints for regulators with low or no flow showed 29 complaints since the beginning of 2016.No sample was returned.Testing could not be performed on regulator.No sample was returned for evaluation.With no additional, related information provided, the customer reported event was not confirmed.The root cause of the reported event cannot be 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 SULFUR HEXAFLUORIDE (SF6) GAS
• Type of Device: INTRAOCULAR GAS
• 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: 17469060
• MDR Text Key: 320679711
• Report Number: 2518435-2023-00024
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657970025
• UDI-Public: 00380657970025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P900067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797002
• Device Lot Number: 232611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1