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

Catalog Number	8065797105
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 pneumatic retinopexy surgery perfluoropropane gas bubble lasted for shorter duration and gas regulator did not enough pressure to force syringe.There was no patient harm.Additional information has been requested none received till date.
Additional Manufacturer Narrative
Additional information was provided in sections d.10, h.6 and h.10.The regulator failed for high flow, but was able to be adjusted to meet specifications.The unit also failed for dead end pressure.The dead end pressure would not stop climbing, no other testing could be performed.Although the customer complaint could not be confirmed, the regulator does not meet release criteria.No investigation into the perfluropropane product could be performed as there was insufficient information provided.A check of the batch production record for regulator from this lot, showed no unusual manufacturing issues.A check of the batch production record for the perfluropropane cylinder could not be performed because a valid lot number was not reported.The expiration date could not be determined.A check of the complaint records showed two other complaints against regulator this lot.A check of confirmed complaints for perfluropropane eye gas not lasting as long in the patient's eye as expected showed no complaints since the beginning of 2016.A check of confirmed complaints for regulators with low or no flow showed 27 complaints since the beginning of 2015.One regulator of this lot was in good condition as received.The regulator was put through final test and inspection.Based upon the information, the root cause of the reported event cannot be determined.At this time, 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
• Common Device Name: 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: 16730652
• Report Number: 2518435-2023-00009
• Device Sequence Number: 17791457
• Product Code: LPO
• UDI-Device Identifier: 00380657971053
• UDI-Public: 00380657971053
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/04/2023

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 Catalogue Number: 8065797105
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GAS TANK REGULATOR; ISPAN GAS TANK REGULATOR
• Patient Sex: Unknown