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

Model Number	FD107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9680353-2022-00021
• Device Sequence Number: 1777692
• Product Code: MEC
• UDI-Device Identifier: 00724995150969
• UDI-Public: 00724995150969
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: FD107
• Device Catalogue Number: FD107
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/12/2022
• 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