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

Model Number	FD107
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the exact serial numbers of the devices subject of the events is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that employees sustained cuts to their hands while handling their three level manifold racks.It is unknown if medical treatment was sought or administered.

• Brand Name: THREE LEVEL MANIFOLD LONG RACK
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 25057124
• Report Number: 9680353-2026-00021
• Device Sequence Number: 9965379
• Product Code: MEC
• UDI-Device Identifier: 00724995150969
• UDI-Public: (01)00724995150969
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: FD107
• Device Catalogue Number: FD107
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• 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