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

Catalog Number 8065797303

Device Problem Gas Output Problem (1266)

Patient Problem No Code Available (3191)

Event Type  Injury  

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.Additional information has been requested.(b)(4).

Event Description

A healthcare professional reported that an ophthalmic gas dispensing regulator was used during multiple vitrectomy surgeries which consistently showed 100psi pressure on the gauge.Some patient eyes had to be subsequently topped off with additional gas.Additional information has been requested.Additional information received clarified that the ophthalmic gas delivered through the suspect regulator was used at varying concentrations.The gas concentration was mixed with unspecified amounts of filtered air.

Manufacturer Narrative

No regulator sample has been received by the contract manufacturer for evaluation.A review of complaints for the last 12 months did not indicate any additional related reports for this regulator device.The root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Per the device contract manufacturer evaluation, a check of the batch production record for reported lot showed no unusual manufacturing issues.A check was completed and there are nine (9) complaint records with previous complaints against the reported lot.However, there were zero (0) complaints observed since january 2012 for any patient requiring to be topped off.As there was no sample received for evaluation and with no additional, related information provided, the customer reported event was not confirmed.It should be noted that if this regulator were being used on a perfluoropropane gas cylinder, then the gauge would stay at 100psi until the bottle was near empty.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
• MDR Report Key: 8495967
• MDR Text Key: 141352634
• Report Number: 1610287-2019-00007
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: 722120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISPAN C3F8 GAS; ISPAN C3F8 GAS
• Patient Outcome(s): Other