MAUDE Adverse Event Report: AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problem Failure to Deliver (2338)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.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 nurse reported that during a vitrectomy surgery an ophthalmic gas could not dispense due to valve could not adjust the gas.There are no report of patient harm.

Manufacturer Narrative

Per the contract manufacturer¿s evaluation, a check of the batch production record for the reported lot number showed no unusual manufacturing issues.Additionally, a check of the complaint records showed one complaint against the reported lot.With no additional, related information provided, the customer reported event was not confirmed.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The root cause of the reported event could not be determined.Therefore, no further actions can be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trend and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: 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 ; 8175514979
• MDR Report Key: 12334312
• MDR Text Key: 267058399
• Report Number: 1610287-2021-00025
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 917807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1