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

Device Problem Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 08/15/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee received a chemical burn on her hand while removing items from the v-pro max sterilizer.The employee washed the affected area and sought medical treatment at the facility's er.No treatment was administered.The employee returned to normal work duties the following day.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, evaluated the v-pro max sterilizer and found the equipment operating to specification.No repairs were required; the reported event could not be duplicated.The steris technician confirmed that the employee was not wearing ppe, gloves, at the time of the event.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." a steris account manager in-serviced the facility on the importance of wearing ppe and drying instruments completely before being placed in the v-pro max sterilizer.No further issues have been reported.

• 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: 4086146
• MDR Text Key: 4895251
• Report Number: 3005899764-2014-00087
• 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: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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 Received: 08/15/2014
• 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