MAUDE MDR 5851811

MDR report key
5851811
Report number
1000515253-2016-00021
Event key
0
Event type
3
Date of event
2016-07-14
Date received
2016-08-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PETER SHEARSTONE
Address
577 APTAKISIC ROAD LINCOLNSHIRE IL 60069 US
Phone
224-224-2245
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UF-1000IAUTOMATED URINALYSIS ANALYZERSYSMEX CORPORATIONLKMUF1000I05366719Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0501. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.