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

Model Number	FD77900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, user facility personnel reattached the hose and continued to utilize the three-level manifold rack.A steris service technician inspected the three-level manifold rack and hose and found no issues with the function or operation with the equipment.The three-level manifold rack was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was unloading the three-level manifold rack from their washer/disinfector, the flexible hose disconnected, and hot water ran out of the hose and contacted the employee's ankle subsequently causing a burn.The employee sought and received medical treatment (bandage).

• Brand Name: THREE-LEVEL MANIFOLD RACK
• Common Device Name: THREE-LEVEL MANIFOLD RACK
• 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17309206
• Report Number: 9680353-2023-00024
• Device Sequence Number: 7261001
• Product Code: MEC
• UDI-Device Identifier: 00724995151218
• UDI-Public: 00724995151218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FD77900
• Device Catalogue Number: FD77900
• 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: 06/13/2023
• Initial Report FDA Received Date: 07/12/2023
• 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