MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. VIROTROL I, CLASS F; KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Model Number	00101F
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At 23:55 on (b)(6) 2023, a traveling technician splashed virotrol i class f, lot 116820 on the right eye when the product tube was opened.The event occurred at (b)(6) general hospital in (b)(6) va, usa.The technician rinsed eyes with eye wash for 15 minutes.The technician has the product insert on hand.Bio-rad technical service provided the product safety data sheet and certificate of analysis for the virotrol i class f, lot 116820.On (b)(6) 2023, the technician notified bio-rad that baseline testing for infectious markers was performed at company's occupational health department.
Additional Manufacturer Narrative
The instruction for use (ifu) provided by bio-rad for testing virotrol i, class f indicated the product contains human source materials and should be considered potentially infectious and handled with the same precautions used with patient specimens in accordance with good laboratory practice.Each human serum or plasma donor unit used in the preparation of this product was tested as required by fda accepted methods.Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus, (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv).Human source materials reactive for viral hepatitis markers and antibodies to retroviruses used to produce this product have been treated to inactivate infectious agents.However, no known test method can assure that products derived from human sources will not transmit infection.It is recommended that this product and all human specimens be handled in accordance with biosafety level 2 practices as described in the united states department of health and human services centers for disease control and prevention (cdc) and national institutes of health (nih), biosafety in microbiological and biomedical laboratories, or other equivalent guidelines.The company address information of the initial reporter was not provided to bio-rad.

• Brand Name: VIROTROL I, CLASS F
• Common Device Name: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine 92618 2017
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: maria zeballos ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9495981200
• MDR Report Key: 16958732
• Report Number: 2016706-2023-00001
• Device Sequence Number: 17449323
• Product Code: KSF
• UDI-Device Identifier: 00847661005544
• UDI-Public: 00847661005544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK930016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 00101F
• Device Catalogue Number: 00100F
• Device Lot Number: 116820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female