MAUDE Adverse Event Report: AIRGAS USA SULFUR HEXAFLUORIDE

Catalog Number	TR9088
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Retinal Detachment (2047)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event: customer reported to distributor that they had been using a gas cylinder of sulfur hexafluoride since (b)(6) 2017 with no issues but two recent cases involving retina re-attachment had re-detached.No further information was provided not were additional reports provided that patients eventually had successful reattachment or not.No individual patient information is known such as age, sex, etc.On 2/27/2018, the distributor reported the case to manufacturer.The actual date of the patient events is unknown other than that they occurred on the same day.The product was returned to manufacturer.Manufacturer conducted a review of the batch product record and discovered no issues.Manufacturer also re-analyzed the cylinder of gas and the product met the original specification.
Event or Problem Description
Event: case 2 of 2.Customer reported to distributor that they had been using a gas cylinder of sulfur hexafluoride since (b)(6) 2017 with no issues but two recent cases involving retina re-attachment had re-detached.No further information was provided not were additional reports provided that patients eventually had successful reattachment or not.No individual patient information is known such as age, sex, etc.On 2/27/2018, the distributor reported the case.The actual date of the patient events is unknown other than that they occurred on the same day.The product was returned to manufacturer.Manufacturer conducted a review of the batch product record and discovered no issues.Manufacturer also re-analyzed the cylinder of gas and the product met the original specification.

• Brand Name: SULFUR HEXAFLUORIDE
• Common Device Name: SULFUR HEXAFLUORIDE
• Manufacturer (Section D): AIRGAS USA; 6141 easton road; plumsteadville PA 18949 0310
• MDR Report Key: 8511389
• Report Number: 2518435-2019-00002
• Device Sequence Number: 11028458
• Product Code: LPO
• UDI-Device Identifier: 10860113000116
• UDI-Public: 10860113000116
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: TR9088
• Device Lot Number: 722125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other