MAUDE Adverse Event Report: SYSMEX CORPORATION UF-1000I; AUTOMATED URINALYSIS ANALYZER

Model Number UF1000I

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

The user reported that the cap and tubing on the reagent were broken prior to the replacement.The user attached tie straps in an attempt to correct the problem.The splash occurred when replacing the reagent that was attached to the broken tubing.No prior notification of the damage was made to the manufacturer nor was there a request for service.The field service engineer confirmed the damaged reagent tubing and replaced it with a new tubing assembly.The sysmex safety data sheet for reagent ufii pack bac states the reagent is a non-hazardous material.For eye contact, it is recommended to remove contact lenses (if worn), rinse open eye for several minutes under running water.If symptoms persist, consult a doctor.General ppe includes protective gloves and safety glasses.This event will be reported based on the physical reaction of the user to the treatment provided for the reagent splash.There was no report of permanent injury to the user.

Event Description

A user was replacing ufii pack bac reagent and splashed reagent in the eyes.Eye protection was not worn as personal protective equipment (ppe) at the time of the event.The user rinsed her eyes out for ten minutes and was sent to employee health.Due to the user's heightened sensitivity to chemicals, employee health treated the user with a "special" eye wash that was not specified in the complaint.The user experienced blurriness as a reaction to the special eye wash and was then treated with steroids.An ophthalmologist determined there was no permanent damage to the user's eyes but requested a few days of rest before returning to work.

• Brand Name: UF-1000I
• Type of Device: AUTOMATED URINALYSIS ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano, noguchichi; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano, noguchichi; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: peter shearstone ; 577 aptakisic road; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 5851811
• MDR Text Key: 51344046
• Report Number: 1000515253-2016-00021
• Device Sequence Number: 1
• Product Code: LKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: UF1000I
• Device Catalogue Number: 05366719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR