MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; HIGH-LEVEL DISINFECTANT

Model Number	73-OPA28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that three different patients experienced an allergic reaction after being exposed to mckesson opa/28 hld.The patients received additional medical treatment; however, it is unknown what type of medical treatment was administered.
Additional Manufacturer Narrative
There are four lot numbers associated with the reported event: (10)607423, (10)628856, (10)630099, (10)638686.The mckesson opa/28 safety data sheet states, "may cause skin irritation.Symptoms may include redness, drying, defatting and cracking of the skin.May produce an allergic skin reaction." steris made multiple attempts to obtain additional information regarding the reported events from the user facility; however, additional information was not provided.A follow-up report will be submitted should additional information become available.
Additional Manufacturer Narrative
In-service training was offered to hufriedy to align between steris and mckesson.Hufriedy provided evidence that they had already counseled mckesson - the distributor to the end user - on the contraindications contained in the rapicide opa 28 labeling.

• Brand Name: MCKESSON
• Common Device Name: HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland drive; suite 4000; richmond VA 23233
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland drive; richmond VA 23223
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21941456
• Report Number: 2150060-2025-00010
• Device Sequence Number: 8547782
• Product Code: MED
• UDI-Device Identifier: 10612479185989
• UDI-Public: (01)10612479185989(10)607423(17)251119(11)231120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120306
• 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,Followup
• Report Date (Section B): 05/01/2025

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: 73-OPA28
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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