MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 PLUS STERILIZER

Device Problem Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/17/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee received a chemical burn on the back of her hand while removing a package from the v-pro 1 plus sterilizer.The employee was sent to the facility's health services to have her hand examined.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the sterilizer and found the unit operating to specification.The reported event could not be duplicated.As a preventive maintenance, the technician replaced the unit's oil and filters, completed a test cycle and returned the unit to operation.The employee subject of the reported event was not wearing the appropriate ppe as recommended in the v-pro 1 plus operator manual.The operator manual (6-11) states, "unload sterilization unit: steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical -resistant gloves when using the sterilization unit." in addition, the operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions." the steris technician confirmed that the facility's protocol is to always wear gloves while unloading the v-pro 1 plus sterilizer.

• Brand Name: V-PRO 1 PLUS 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: 3677669
• MDR Text Key: 16594460
• Report Number: 3005899764-2014-00016
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/13/2014

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: 02/17/2014
• Initial Date FDA Received: 03/13/2014
• 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