MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 7% BSA; IN-VITRO DIAGNOSTICS

Catalog Number	8262487
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation concluded that 7% bovine serum albumin (bsa) fluid splashed into the eye of an operator while opening the fluid vial when performing daily maintenance on a vitros xt 3400 chemistry system.The assignable cause of this event is user error, as the operator did not use proper personal protective equipment (safety glasses or face shield) while handling the 7% bsa fluid.The 7% bsa safety data sheet (sds) states the following when contact with the eye occurs: -rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids.Consult a physician.Eye/face protection: -wear safety glasses with side shields (or goggles).Additionally "this product contains animal blood derivatives.No known test method can offer complete assurance that products derived from animal blood will not transmit infectious agents.Therefore, all blood derivatives should be considered potentially infectious.It is recommended that these reagents be handled using established good laboratory working practices." bsa is an aqueous solution of bovine serum, inorganic salts, and preservatives used to dilute samples.Per the safety data sheet (sds), 7% of bsa contained animal blood derivatives with no other substances considered hazardous to health at their given concentration.Thus, there is a risk of zoonotic infection from contact with animal blood derivatives.Although the materials for making the reagents were tested negative for blood-borne pathogens, no test method can assure that the product is completely safe from potential pathogens.There might be unknown pathogens or pathogens that were not tested.So, a disease transmission due to the exposure cannot be excluded.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that 7% bovine serum albumin (bsa) fluid splashed into the eye of an operator while opening the fluid vial when performing daily maintenance on a vitros xt 3400 chemistry system.The operator was seen by an emergency room provider on (b)(6) 2025, who stated that the operators eye appeared unharmed.The operator did not feel and currently does not feel any itching, burning or pain in the eye since the event.A medical consultation was obtained from an ortho medical safety officer on (b)(6) 2025: an operator had a splash of 7% bsa (bovine serum albumin) solution into their left eye while trying to remove the rubber cap on the bottle.The left eye was washed with eye saline and had unspecified treatment at the emergency room (er).Based on the available information, the risk of serious eye injury on the operator is unlikely.However, this event meets the definition of a serious injury due to the uncertainty of infection risk.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS 7% BSA
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21857708
• Report Number: 1319808-2025-00017
• Device Sequence Number: 4709185
• Product Code: DCF
• UDI-Device Identifier: 10758750004652
• UDI-Public: (01)10758750004652
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/17/2025

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 Catalogue Number: 8262487
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown