MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER S40 STERILANT CONCENTRATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated that an employee placed a cup of s40 sterilant into a system 1e processor to begin a cycle.The employee attempted to start the cycle however, the cycle would not initiate.As the cycle would not initiate, the employee became aware that the processor was not in service.When the employee realized that the system 1e processor was not in service, she removed the system 1e tray which still contained the open s40 sterilant cup, and began to move the tray to a different system 1e processor.During this time, the employee felt a burning sensation on her foot.A previous employee did not place an out of service tag on the system 1e processor which would instruct other employees to not utilize the device.The employee subject of the reported event did not follow proper disposal instructions of the s40 sterilent cup before transport of the tray.The proper disposal procedures are outlined in section 3 of the system 1e operator manual.Steris is unable to determine how the liquid from the cup came into contact with the employee's foot as the cup is designed to keep peracetic acid enclosed in the acid capsule until the processor's cycle prompts siphoning into the mix dilution.Steris discussed the proper s40 disposal procedures with user facility personnel.

Event Description

The user facility reported that an employee was transferring a system 1e tray from one processor to another, when liquid fell onto the employee's foot.The employee sought medical treatment.

• Brand Name: S40 STERILANT CONCENTRATE
• Type of Device: STERILANT CONCENTRATE
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6180700
• MDR Text Key: 62598225
• Report Number: 3003950207-2016-00013
• Device Sequence Number: 1
• Product Code: MED
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other