MAUDE Adverse Event Report: AIR LIQUIDE ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number	8065797105
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
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 physician reported that during a surgery gas was not flowing from the gas cylinder and the pressure gauge indicated zero pressure.Surgery was completed using a backup gas cylinder.There was no report of patient harm.
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.10.The octafluoropropane (c3f8) tank was not returned for evaluation.A review of the batch production record for lot 917001 showed no unusual manufacturing issues.The expiration date of the batch is may 31, 2021.A review of the complaint records showed one other complaint against lot 917001.With no additional, related information provided, the customer reported event was not confirmed.The root cause cannot be determined conclusively.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).
Additional Manufacturer Narrative
H.10, correction: section d.4 and h4 the manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer (Section G): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13168672
• Report Number: 1610287-2022-00002
• Device Sequence Number: 5926194
• Product Code: LPO
• UDI-Device Identifier: 00380657971053
• UDI-Public: 00380657971053
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: P900066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

1 Device was Involved in the Event

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 8065797105
• Device Lot Number: 917001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 03/07/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/11/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown