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

Catalog Number 8065797303

Device Problem Device Inoperable (1663)

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

Event Date 11/13/2017

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

Event Description

A nurse reported that two ophthalmic gas dispensing regulators would not work and were unable to provide gas during surgery.Patient impact information is unknown.Additional information has been requested.Additional information received clarified that the gas was unable to be dispensed through the regulator therefore, the patients had to receive oil instillation instead of gas.There was no harm to any patient.No further information is available.

Manufacturer Narrative

Two regulator samples were returned to the contract manufacturer for investigation.The returned samples were tested per their final test procedure and it was found that one regulator did not pass the creep testing above 10 pounds per square inch psi while the other regulator passed all testing.Per manufacturer, not passing the creep test would not account for the customer complaint of the regulator ¿not working¿ as it would actually deliver more pressure than standard.A review of the manufacturing records for this lot number noted that the product met specifications at the time of release.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).

• 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: 7074205
• MDR Text Key: 93765947
• Report Number: 1610287-2017-00073
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 722120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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