FDA.reportPublic FDA data

MAUDE MDR 2388514

MDR report key
2388514
Report number
3005899764-2010-00013
Event key
0
Event type
3
Date of event
2010-04-29
Date received
2010-06-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS LINDSEY MCGOWAN
Address
5960 HEISLEY RD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13017 ETO STERILIZERSTERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.FLFM1301043* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-06-2401. O

Event Narratives#

D

Patient 1

(B)(4).

N

Patient 1

THE USER FACILITY REPORTED THAT A THIRD PARTY CONTRACTOR THEY HIRED TO CHECK AIR PRESSURE DIFFERENTIALS, AIR EXCHANGES, AND PREFORM EXPOSURE MONITORING FOUND AN OPEN PETCOCK VALVE ON THE FACILITY'S EXHAUST LINE ALLOWING ETHYLENE OXIDE TO BE EXHAUSTED INTO THE STERILIZER SERVICE ROOM. THE CONTRACTOR STOPPED THE LEAK BY CLOSING THE PETCOCK VALVE. THERE WERE NO REPORTED INJURIES AS A RESULT OF THIS EVENT. THE PETCOCK VALVE IS USED TO EMPTY WATER AND DEBRIS THAT MAY HAVE ENTERED THE EXHAUST LINE FROM OUTSIDE SOURCES SO THAT THE WATER AND/OR DEBRIS DOES NOT ENTER INTO THE ETHYLENE OXIDE STERILIZER. THE VALVE IS ATTACHED TO THE EXHAUST LINE WHICH RUNS FROM THE SERVICE ROOM TO THE OUTSIDE OF THE BUILDING. THE USER FACILITY CONCLUDED THE VALVE WAS OPENED INADVERTENTLY BY A FACILITY EMPLOYEE AS IT SITS AT FOOT LEVEL ALONG THE FACILITY EXHAUST LINE A FEW FEET AWAY FORM THE STERIS ETHYLENE OXIDE STERILIZER. STERIS HAD NOT SERVICED THE EQUIPMENT PRIOR TO THE REPORTED EVENT. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE UNRELATED TO THE STERIS ETHYLENE OXIDE STERILIZER AS THE PETCOCK VALVE LEFT OPEN IS PART OF THE USER FACILITY'S EXHAUST LINE AND IS NOT PART OF THE STERILIZER.