MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 60 STERILIZER

Device Problem Break (1069)

Patient Problem Burning Sensation (2146)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

No report of procedure delay or cancellation.All instruments were reprocessed prior to use in procedures.The user facility stated that the employee removed the scbi from the sterilizer.The employee then touched her cheek with her hand and felt a burning sensation.She rinsed the area with water and the sensation subsided.The scbi which was used was identified to be damaged, allowing hydrogen peroxide to become trapped within the media of the ampoule causing the reported burn.The steris verify v24 self-contained biological indicator instructions for use states "caution: in some instances, residual hydrogen peroxide may be trapped within the media of a damaged ampoule.Should this occur avoid direct contact with the scbi and its contents.Place entire test pouch and its contents into a steam compatible container and dispose according to the instructions at the end of this document." steris quality inspected the retains of the lot number and confirmed there was no evidence of damage.The dhr was reviewed and no abnormalities were identified.A steris service technician inspected the sterilizer and found the unit to be operating properly.No issues with the function or operation of the sterilizer was identified.A steris account manager performed in-service training on the proper use and operation of the scbi and v-pro 60 sterilizer, including proper handling/inspection of the scbi.No additional issues have been reported.

Event Description

The user facility reported an employee felt a burning sensation on her cheek after removing a broken steris celerity hp self-contained biological indicator from a v-pro 60 sterilizer following a completed sterilization cycle.The employee did not seek medical treatment and returned to work.

• Brand Name: V-PRO 60 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 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8312932
• MDR Text Key: 137557900
• Report Number: 3005899764-2019-00009
• 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: 02/06/2019

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: 01/07/2019
• Initial Date FDA Received: 02/06/2019
• 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