MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problem Gas Output Problem (1266)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

A customer reported that an ophthalmic gas would not dispense out of the regulator.Procedure details and patient impact were not reported.Additional information has been requested none received till date.Additional information received from the customer indicated that the event occurred during a surgery.The surgery was completed with an alternate regulator.There was no patient harm.

Manufacturer Narrative

This report originally filed under mfg report num 1610287-2022-00063.All future reports will be submitted under mfg report num reflected in this report.The regulator was not returned for evaluation.A review of the batch production record for lot: 131411 showed no unusual manufacturing issues.A review of the complaint records showed no other complaints against lot: 131411.A review of confirmed complaints for regulators with low or no flow showed 27 complaints since the beginning of 2015 (151-04, 16b-08, 16e-06, 17h-07, 17j-03, 17j-10, 17k-13, 17l-06, 18a-09, 18c-02, 18f-01, 18f-16, 18h-02, 19b-01, 19c-17, 19d-04, 19e-06, 19f-08, 19h-01, 19h-02, 191-06, 19k-05, 20f-04, 201-08, 20j-04, 20j-12, and 21 g-13).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).

• Brand Name: ISPAN GAS TANK REGULATOR
• 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: 15824323
• MDR Text Key: 307706645
• Report Number: 2518435-2022-00038
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• 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: 8065797303
• Device Lot Number: 131411
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1