MAUDE Adverse Event Report: STERIS CANADA ULC THREE LEVEL MANIFOLD RACK TO WASHER

Model Number FD107

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

Patient Problem Laceration(s) (1946)

Event Date 06/14/2022

Event Type  Injury  

Manufacturer Narrative

A steris service technician, steris account manager and steris clinical educator arrived onsite following the reported event.User facility personnel were unable to identify the specific manifold rack that the employee was handling.The technician, account manager and clinical educator inspected all 20 manifold racks at the user facility and no rough edges or burrs were noted.The manifold racks were operating to specification and returned to service.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a cut to their finger while manually pulling a manifold rack out of their washer.The employee sought and received medical treatment (stitches).

• Brand Name: THREE LEVEL MANIFOLD RACK TO WASHER
• Type of Device: THREE LEVEL MANIFOLD RACK TO WASHER
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14986911
• MDR Text Key: 295692935
• Report Number: 9680353-2022-00021
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995150969
• UDI-Public: 00724995150969
• 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: 07/12/2022

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
• Device Model Number: FD107
• Device Catalogue Number: FD107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/12/2022
• 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