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

Catalog Number 8065797303

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

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 health professional reported that an ophthalmic gas dispensing regulator repeatedly would not fill a syringe after attempting the use for five minutes.Procedure details, patient involvement and patient impact information is unknown.Additional information received clarified that the ophthalmic gas dispensing regulator would not dispense gas prior to the start of a vitrectomy surgery.An alternate gas was obtained in order to proceed with the scheduled procedure.There was no patient involvement or patient impact associated with this reported event.

Manufacturer Narrative

The contract manufacturer of the reported device was notified of this event.To date, the contract manufacturer's investigation results have not been received.A review of complaints for the last 12 months did indicate five additional related reports for this regulator device.With no additional, related information provided, the customer's reported event could not be confirmed.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

One ophthalmic gas dispensing regulator was received by the contract manufacturer for evaluation.The regulator was in good condition as received and was put through final inspection tests.The returned regulator passed all release criteria.The regulator was tested multiple times on two different days with the same result.The customer reported event could not be confirmed or replicated.A review of the batch production record for the reported lot was performed and confirmed that the product met specifications at the time of release.A review of the complaint records showed seven other complaints against the reported lot number since release.The returned regulator was found to meet specifications therefore, the customer reported event could not be confirmed nor replicated and root cause could not be determined.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: 9643771
• MDR Text Key: 182796660
• Report Number: 1610287-2020-00003
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: 819708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISPAN C3F8 PERFLUOROPROPANE