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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. VPRO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. VPRO STERILIZER Back to Search Results
Event Date 02/12/2013
Event Type  No Answer Provided  
Event Description

The user facility reported that after a completed cycle an employee removed a peel pack and liquid contacted her finger. The employee reported peroxide contacted her finger causing a small blister. No medical attention was sought and no work was missed by employee. The employee washed her hands thoroughly and returned to work. No procedural delays or cancellations reported.

 
Manufacturer Narrative

A steris service technician arrived on site to review the incident and inspected the unit. An intermittent leak in the sv4 injector valve was found. The leak rate was recorded at 0. 056 and review of previous cycles showed only a minor variation in pressure rises but remaining within specification limits. The technician replaced the injector valve, ran a test cycle and confirmed the unit operational. The service technician confirmed the employee subject of this event was not wearing gloves (ppe) when removing processed packs from the sterilizer. The vpro operating manual states (2-1), "ppe -personal protective equipment including goggles or face shield and chemical-resistant gloves. Ppe required per task will vary depending upon hazard of the task". A steris in-service training about proper use of ppe was offered by the technician at the time of his visit and performed at the facility on (b)(6) 2013.

 
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Brand NameVPRO STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 6719 0
MX  67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 6719 0
MX  67190
Manufacturer Contact
lindsey mcgowan
5960 heisley road
mentor , OH 44060
4403927519
MDR Report Key2994643
Report Number3005899764-2013-00016
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/08/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/12/2013
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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