BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 7% BSA

    MDR report key: 21857708 · Received April 17, 2025

    Report

    Report Number
    1319808-2025-00017
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    DCF
    UDI-DI
    10758750004652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777009 VITROS 7% BSA IN-VITRO DIAGNOSTICS DCF ORTHO-CLINICAL DIAGNOSTICS, INC. NOT PROVIDED 10758750004652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown