MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN GAS TANK REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Catalog Number 8065797303

Device Problem No Flow (2991)

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 customer reported that prior to the surgery, they observed that the ophthalmic gas regulator had an issue with extremely slow gas release and occasional non-release.Procedure details and patient impact were not reported.Additional information has been requested none received till date.

Manufacturer Narrative

Correction information was provided in section d.4 and h.4.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in sections h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot number was performed.No similar complaints were reported for the product lot under investigation.A check of the batch production record for this lot, showed no unusual manufacturing issues.A check of the complaint records showed no other complaints against this lot.A check of confirmed complaints for regulators with low or no flow showed (b)(4) complaints since the beginning of 2016.As of 03 november 2023 no sample has been returned.Testing cannot be performed.No sample was returned for evaluation.With no additional, related information provided, the customer reported event was not confirmed.Based upon the information obtained, the root cause of the reported event cannot be determined at this time.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: REGULATOR, PRESSURE, GAS CYLINDER
• 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: 18028814
• MDR Text Key: 326840139
• Report Number: 2518435-2023-00040
• Device Sequence Number: 1
• Product Code: CAN
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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: 313711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1