MAUDE MDR 8311797

MDR report key
8311797
Report number
9680353-2019-00008
Event key
0
Event type
3
Date of event
2019-01-14
Date received
2019-02-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL DAVY
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 1E PROCESSORSYSTEM 1E PROCESSORSTERIS CANADA CORPORATIONMEDY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-060

Event Narratives#

N

Patient 1

PRIOR TO THE REPORTED EVENT, FACILITY PERSONNEL IDENTIFIED A "FILL TIME" ERROR ASSOCIATED WITH THEIR SYSTEM 1E PROCESSOR AND REMOVED THE UNIT FROM SERVICE FOR REPAIR. FORGETTING THAT THE UNIT WAS OUT OF SERVICE, AN EMPLOYEE INSERTED AN S40 STERILANT CUP INTO THE SYSTEM 1E PROCESSOR. MOMENTS LATER, THE EMPLOYEE REALIZED THAT THE UNIT WAS NOT IN SERVICE AND REMOVED THE FULL PUNCTURED CUP OF STERILANT FROM THE UNIT WITHOUT PROPER PPE. THE EMPLOYEE REMOVED THE STERILANT CUP FROM THE UNIT WHICH RESULTED IN A SMALL AMOUNT OF STERILANT CONTACTING THE EMPLOYEE'S FINGER. THE OPERATOR MANUAL STATES THE PROPER PPE REQUIRED WHEN DISPOSING OF THE S40 STERILANT CUP, "TO DISPOSE OF PARTIALLY FILLED, LEAKING, DAMAGED, OR EXPIRED STERILANT CONTAINERS, PUT ON APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (CHEMICAL-RESISTANT GLOVES, APRON, GOGGLES OR FACE SHIELD, AND ANY OTHER PROTECTION REQUIRED BY FACILITY PROCEDURES). WEAR PROTECTIVE ATTIRE FOR THE ENTIRE PROCEDURE." A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND INSPECTED THE UNIT. THE TECHNICIAN MADE THE APPROPRIATE REPAIRS TO ADDRESS THE FILL TIME ERROR, COMPLETED PREVENTIVE MAINTENANCE ACTIVITIES, RAN A TEST CYCLE, AND RETURNED THE UNIT TO SERVICE. WHILE ONSITE, THE TECHNICIAN COUNSELED FACILITY PERSONNEL ON PROPER USE AND OPERATION OF THE SYSTEM 1E PROCESSOR AND S40 STERILANT, SPECIFICALLY, THE IMPORTANCE OF WEARING PROPER PPE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE USER FACILITY REPORTED THAT AN EMPLOYEE FELT A BURNING SENSATION ON HER FINGER WHILE REMOVING A FULL S40 STERILANT CUP FROM THEIR SYSTEM 1E PROCESSOR. THE EMPLOYEE RINSED HER FINGER UNDER COLD WATER AND AS A PRECAUTION WAS SENT THE EMERGENCY ROOM. THE EMPLOYEE DID NOT MISS ANY DAYS OF WORK.