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

Device Problem Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/08/2015

Event Type  No Answer Provided  

Event Description

The user facility reported an employee experienced a chemical burn.The employee rinsed the area with water and did not seek medical treatment; the employee resumed normal work duties.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the facility's v-pro max sterilizer, and found it to be operating properly.The sterilizer was returned to service and no additional issues have been reported.The technician was informed that the employee obtained a chemical burn and experienced discoloration to her finger.The employee came into contact with liquid and was not wearing proper ppe, specifically gloves, at the time of the reported event.Section 1 of the operator manual for the v-pro max sterilizer states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions." also, "when handling hydrogen peroxide, wear appropriate personal protective equipment (ppe) and observe all safety precautions.Section 8.2 of the safety data sheet for vaprox hc hydrogen peroxide sterilant recommends, "personal protection: eye and face protection: chemical splash goggles.Protective gloves: rubber, neoprene or vinyl.Other protective clothing and equipment: polyester or acrylic full cover clothing and rubber boots are recommended." since the reported event, the user facility has reviewed the processes for operating the v-pro max sterilizer and in-service training has been provided on the proper use of ppe.

• Brand Name: V-PRO MAX STERILIZER
• Type of Device: STERILIZER
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4821768
• MDR Text Key: 5904459
• Report Number: 3005899764-2015-00042
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/05/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other