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

Model Number 9305-100ML

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2022

Event Type  malfunction  

Event 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
• Type of Device: MEDIA, REPRODUCTIVE
• Manufacturer (Section D): FUJIFILM IRVINE SCIENTIFIC, INC.; 2511 daimler street; santa ana CA 92705
• MDR Report Key: 16120606
• MDR Text Key: 306894894
• Report Number: 16120606
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 12/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female