MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX 2 STERILIZER

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found the unit to be operating properly.No issues with the function or operation were identified and the sterilizer was returned to service.Based on the description of the event, the bi was likely damaged prior to the cycle allowing hydrogen peroxide to become trapped and remain after the cycle subsequently causing the reported event to occur.The bi media is water-based and non-toxic.A steris clinical education specialist spoke with user facility personnel and learned that the employee was not wearing chemical-resistant gloves.The reported burn is attributed to the employee not wearing proper ppe, specifically chemical-resistant gloves, while operating their v-pro max 2 sterilizer.The vaprox hc sterilant safety data sheet states, "8.2 exposure controls: hand protection: wear protective gloves.Use gloves constructed of chemical resistant materials such as nitrile, neoprene, rubber, or vinyl if frequent or prolonged contact is expected." the v-pro max 2 sterilizer operator manual (1-2) 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.When handling hydrogen peroxide, wear appropriate personal protective equipment." the clinical education specialist counseled user facility personnel on the importance of wearing proper ppe, specifically gloves, and proper handling/inspection of bis for damage while operating their v-pro max 2 sterilizer.No additional issues have been reported.

Event Description

The user facility reported that while handling biological indicators (bis) that were processed in a v-pro max 2 sterilizer, an employee experienced a burn on their hands.It is unknown if medical treatment was sought or administered.

• Brand Name: V-PRO MAX 2 STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18335284
• MDR Text Key: 331060346
• Report Number: 3005899764-2023-00069
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: 00724995158354
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• 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