MAUDE Adverse Event Report: CORPORATION STERIS CANADA THREE LEVEL MANIFOLD RACK

Model Number	FD009
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a cut on their arm while loading items onto their three level manifold rack.The employee did not seek medical treatment.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived on site and confirmed the rack to have sharp edges.The technician filed down the edges, tested the function and operation of the rack, and returned it to service.A 3-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: THREE LEVEL MANIFOLD RACK
• Common Device Name: THREE LEVEL MANIFOLD RACK
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22018830
• Report Number: 9680353-2025-00020
• Device Sequence Number: 21203196
• Product Code: MEC
• UDI-Device Identifier: 00724995150884
• UDI-Public: (01)00724995150884(11)230321
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: FD009
• Device Catalogue Number: FD009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown