MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER GENESIS QTR-LENGTH CONTAINER

Model Number	CD0-4C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow-up with user facility personnel, it was stated that another employee cut their finger on a container.User facility could not confirm if it was the employee subject of the reported event or another employee.The device history record was reviewed for the subject lot and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated.Steris has made multiple attempts to obtain additional event information however, the user facility has not responded.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained an injury (laceration) to her thumb while opening a genesis container.It is unknown the type of medical treatment that may have been sought or administered.

• Brand Name: V. MUELLER GENESIS QTR-LENGTH CONTAINER
• Common Device Name: CONTAINER
• Manufacturer (Section D): STERIS CORPORATION; 17820 englewood dr.; cleveland OH 44130
• Manufacturer (Section G): STERIS CORPORATION; 17820 englewood dr.; cleveland OH 44130
• Manufacturer Contact: daniel davy ; 17820 englewood dr.; cleveland, OH 44130 ; 4402597401
• MDR Report Key: 25679167
• Report Number: 1526531-2026-00001
• Device Sequence Number: 14616803
• Product Code: KCT
• UDI-Device Identifier: 10885403018909
• UDI-Public: (01)10885403018909(10)13762542B26
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/01/2026

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: CD0-4C
• Device Catalogue Number: CD04C
• Device Lot Number: (10)13762542B26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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