MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number 8065797105

Device Problems Gas Output Problem (1266); Appropriate Term/Code Not Available (3191)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

A customer reported that perfluoropropane gas bubble in eye reduced in size prematurely in the patient eye.Procedure was completed and patient harm was not reported.Additional information has been received indicating that the event occurred during surgery but not noted until post operative (post-op).The gas fill was noted to be low at post-op and perfluoropropane was not dispensed.

Manufacturer Narrative

This report originally filed under mfg report num 1610287-2022-00027.All future reports will be submitted under mfg report num reflected in this report.The c3f8 tank was not returned for evaluation.A review of the batch production record could not be performed because the lot number was not reported.The expiration date could not be determined.A review of the complaint records could not be performed because the lot number was not provided.A review of confirmed complaints for leaking cylinders of this type or for c3f8 not lasting as long as expected.Both were for cylinders that leaked at the valve to cylinder connection.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 PERFLUOROPROPANE (C3F8) 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: 15824179
• MDR Text Key: 304509382
• Report Number: 2518435-2022-00035
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657971053
• UDI-Public: 00380657971053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797105
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Sex: Male