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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. V-PRO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO STERILIZER Back to Search Results
Event Date 01/15/2013
Event Type  No Answer Provided  
Event Description

The user facility reported that after a completed cycle, an employee went to retrieve instruments from the sterilizer and experienced discoloration to her hands. The employee self treated by washing her hands and the discoloring went away. No additional medical treatment was sought or administered. No blistering was reported. No procedural delays or cancellations reported.

 
Manufacturer Narrative

A steris service technician inspected the sterilizer and found it to be operating properly; no issues were noted. The biological indicator (bi) present in the cycle was cracked after the cycle. The user facility stated that they ran out of tyvek pouches so they did not place the bi into a pouch during the cycle. The crack in the bi allowed the material in the vial to contact the outside of the wrapping material surrounding the instruments and allowing hydrogen peroxide to contact the bi material. When the employee retrieved the instrument pack her hands contacted the liquid. The employee was not wearing proper ppe (gloves) at the time of the reported event. The operator 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 hazards of the task. " the steris account manager stated that user facility staff have been in-serviced multiple times on the proper use and operation of the sterilizer.

 
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Brand NameV-PRO 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 Key2961828
Report Number3005899764-2013-00007
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/14/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/15/2013
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

Patient TREATMENT DATA
Date Received: 02/14/2013 Patient Sequence Number: 1
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