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

Device Problem Insufficient Information (3190)

Patient Problem Eye Injury (1845)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

The employee rinsed her eyes with water and went to the er.User facility personnel contacted steris to discuss disposal methods for expired s40 sterilant.The operator manual states (pp.3-4), "if the system 1e processor is unavailable, isolate the partially filled, leaking, damaged, or expired sterilant container until the processor is available or perform a manual disposal as described below." "carefully handle the partially filled, leaking, damaged, or expired sterilant container and place upside down on a flat surface or in a sink." the reported event may be attributed to improper disposal methods by the employee.Should the proper manual disposal method had been followed, the employee would not have gotten liquid in her eye.A steris account manager offered in-service training on the proper disposal methods to user facility personnel however, the user facility declined.

Event Description

The user facility reported an employee was manually disposing expired sterilant and in the process liquid contacted her eye.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 6845837
• MDR Text Key: 85295384
• Report Number: 3003950207-2017-00006
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• 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