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

Catalog Number 8065797005

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 customer reported that the an ophthalmic gas cylinder was left unplugged and sometimes there was not enough gas when using it.The procedure details and patient impact were not reported.

Manufacturer Narrative

Additional information provided in sections h.6.And h.10.No further information was able to be obtained from this customer.With no additional, related information provided, the customer¿s reported event was not able to be confirmed.A check of the batch production record could not be done because no lot number was reported.A check of complaint records for the lot could not be done because no lot number was reported.A check of confirmed complaints for low pressure or empty tanks of this type showed seven since the beginning of 2016.No sample was returned for evaluation.Based upon the information provided, the customer reported event was not confirmed.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: 17755208
• MDR Text Key: 323496153
• Report Number: 2518435-2023-00034
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657970056
• UDI-Public: 00380657970056
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1