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

Catalog Number 8065797303

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.Additional information has been requested.This is the second of two reports from this reporter.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that two ophthalmic gas regulators were unable to fill syringes.Procedure details, patient involvement and patient impact information is unknown.Additional information received clarified that the gas regulators were unable to fill the syringes prior to performing vitrectomy procedures.There was no patient involvement thus, no impact to any patient.

Manufacturer Narrative

A sample has been received by the device contract manufacturer however, no evaluation results have been received from the contract manufacturer to date.No further information was able to be obtained from this customer.With no additional, related information provided, the customer's reported event was not able to be confirmed.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.

Manufacturer Narrative

Per the contract manufacturer's evaluation, one regulator from the reported lot number was received in good condition.The regulator was put through final inspection and test.The regulator was found to fail inspection for insufficient flow, but was able to be adjusted to meet final release criteria.The reported event could be confirmed because although flow was present, it was far below specifications.A review of the batch production record for the reported lot number showed no unusual manufacturing issues.A review of the complaint records showed two prior complaints against the reported lot.The root cause of the reported event can be attributed to a nonconforming regulator.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: 8876051
• MDR Text Key: 153872911
• Report Number: 1610287-2019-00023
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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: 901708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISPAN SF6 GAS