MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-24 for 3017 ETO STERILIZER M1301043 manufactured by Steris Mexico, S. De R.l. De C.v..
[2499479]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9578907]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2010-00013 |
| MDR Report Key | 2388514 |
| Report Source | 06 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-06-24 |
| Date of Event | 2010-04-29 |
| Date Mfgr Received | 2010-05-27 |
| Date Added to Maude | 2012-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3017 ETO STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2010-06-24 |
| Model Number | M1301043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-24 |