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

Catalog Number 8065797303

Device Problem Gas Output Problem (1266)

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

Event Date 07/27/2017

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.(b)(4).

Event Description

A materials manager reported that an ophthalmic gas dispensing regulator valve would intermittently indicate the available gas pressure, but was unable to dispense gas prior to the start of vitrectomy surgery.There was no patient harm associated with this event that was noted prior to surgery.

Manufacturer Narrative

A sample is available that has not yet been received by manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A review of the manufacturing records did not reveal any related nonconformity during manufacturing for this product.Based on qa assessment, the product met specifications at the time of release.An ophthalmic gas dispensing regulator sample was received and testing was performed on the returned sample.The creep test performance was below specification.Additionally, testing of the regulator flow at 320 psi headspace pressure was performed which was found to meet specifications.While the complaint was confirmed, it is however unknown whether the nonconformities found would have contributed to the customer¿s observations.The root cause 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).

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6791444
• MDR Text Key: 82881842
• Report Number: 1610287-2017-00059
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• 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: 702009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other