MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6802413

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

The investigation concluded an operator was splashed in the eye while cleaning the tip locator on the vitros 5600 system with di water and a cotton swab.It is possible that dried sample could have washed off the surface of the tip locator and included in the fluid which splashed into their eye.The cause of this event is user error, as the customer did not use proper personal protection equipment (safety glasses) while performing daily maintenance actions on the vitros 5600 system.It is possible that dried sample could have washed off the surface of the tip locator and included in the fluid which splashed into their eye.The potential for a blood borne pathogen infection due to the event cannot be ruled out.The operator had no adverse reactions or symptoms as a result of this event, and no additional medical treatment was sought.The laboratory supervisor who reported the issue agreed to contact ortho if further assistance was needed.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report an operator was splashed in the eye while cleaning the tip locator on the vitros 5600 system with di water and a cotton swab.It is possible that dried sample could have washed off the surface of the tip locator and included in the fluid which splashed into their eye.Based on a consultation with the ortho medical safety officer dr.(b)(6) 2013, this event is considered a potential serious injury.A splash of clinical laboratory medical waste to the face of a health care worker is considered as blood borne pathogen exposure to skin and mucosa.Due to the unknown pathogen contents and pathogen concentrations in the waste, the potential of infection due to the exposure cannot be ruled out; however, the probability of infection should be low.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number 2601843 and reportability assessment 605558.

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18986328
• MDR Text Key: 338704207
• Report Number: 1319681-2024-00024
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: 10758750002740
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1