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 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 physician reported that ophthalmic gas not enough pressure to push the syringe plunger and no patient harm was reported.

Manufacturer Narrative

No lot number was reported and there was no sample returned for evaluation.With no additional, related information provided, the customer reported event was not confirmed.A check of the production record could not be performed because a valid lot number was not reported.The expiration/manufacture date could not be determined.A check of the complaint records could not be performed because a valid lot number was not provided.A check of confirmed complaints for regulators with low or no flow showed 27 complaints since the beginning of 2015.Based upon the information provided (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).

Manufacturer Narrative

The initial decision to report was incorrect resulting in the initial report being submitted in error.This event not enough pressure to push the syringe plunger is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be scheduled under mfg report number: 2518435-2023-00008.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: 16707988
• MDR Text Key: 312973693
• Report Number: 2518435-2023-00008
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• 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