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

Catalog Number 6802413

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The investigation concluded that waste fluid that likely contained patient sample splashed into the eye of an operator while emptying the waste container from a vitros 5600 integrated 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 emptying the waste container.Under the daily maintenance procedure of the on-board user documentation (vdocs), it warns that the waste container will contain trace amounts of sample fluid.Handle waste as biohazardous material.Remove waste according to instructions and accepted laboratory procedures.The investigation concluded that the incident involved exposure to mucosal tissue with the waste fluid.Therefore, 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.The customer stated that no further treatment for the operator was scheduled or expected.

Event Description

An operator was emptying a waste container from a vitros 5600 integrated system into a sink.While emptying the container, some fluid splashed into one of the operator¿s eyes.The operator went to the emergency room (er) where their eyes were flushed for 15 minutes and they were given eye drops.The operator was not wearing safety glasses or a face shield.Under the daily maintenance procedure of the on-board user documentation (vdocs), it warns that the waste container will contain trace amounts of sample fluid.Handle waste as biohazardous material.Remove waste according to instructions and accepted laboratory procedures.The operator had no adverse reactions or symptoms as a result of this event, and no additional medical treatment was sought.The customer stated that no further treatment for the operator was scheduled or expected.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10384857
• MDR Text Key: 209584077
• Report Number: 1319681-2020-00064
• Device Sequence Number: 1
• Product Code: JJE
• 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
• Type of Report: Initial
• Report Date: 08/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other