MAUDE Adverse Event Report: CORPORATION STERIS CANADA N/A; MANIFOLD RACK

Model Number	FD74900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found the washer and the three level manifold rack to be operating according to specifications.No issues were noted with the function and operation.As a precaution, the technician filed the edges on the bottom of the shelves of the rack.The unit was tested, confirmed to be operating according to specification, and returned to service.While onsite, the technician discussed the proper use and operation of the three level manifold rack, specifically the precautions regarding the edges of the rack.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee injured their hand while unloading a three level manifold rack from their amsco 7052hp washer.The employee self-treated using mattison glue, steri-strips and tegaderm and returned to work.

• Brand Name: N/A
• Common Device Name: 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: 19995861
• Report Number: 9680353-2024-00028
• Device Sequence Number: 8460625
• Product Code: MEC
• UDI-Device Identifier: 00724995151157
• UDI-Public: (01)00724995151157
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/15/2024

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: FD74900
• Device Catalogue Number: FD74900
• 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: 07/19/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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