MAUDE Adverse Event Report: FUJIFILM IRVINE SCIENTIFIC, INC. OIL FOR EMBRYO CULTURE; MEDIA, REPRODUCTIVE

Model Number	9305-100ML
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Embryologist noticed degeneration of embryos treated with mineral oil used to prevent evaporation.The embryologist then performed a qa/qi test of the mineral oil on mouse embryos and noted same effect.Approximately 20 patients may be affected.The oil has been removed from use.Manufacturer response for mineral oil, oil for embryo culture (per site reporter) no response to date.

• Brand Name: OIL FOR EMBRYO CULTURE
• Common Device Name: MEDIA, REPRODUCTIVE
• Manufacturer (Section D): FUJIFILM IRVINE SCIENTIFIC, INC.; 2511 daimler street; santa ana CA 92705
• MDR Report Key: 16120606
• Report Number: 16120606
• Device Sequence Number: 6564798
• Product Code: MQL
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/21/2022
• Report Date (Section F): 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 9305-100ML
• Device Catalogue Number: 9305
• Device Lot Number: 0000011351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 12/21/2022