MAUDE Adverse Event Report: STERIS CORPORATION REVITAL-OX RESERT DISINFECTANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility was provided a copy of the safety date sheet (sds).The user facility could not confirm if the liquid observed was in fact revital-ox resert disinfectant.No additional issues have been reported.
Event or Problem Description
The user facility reported via a chemtrec report that during a patient procedure, liquid was observed in the probe bag.User facility personnel were concerned that the liquid could be revital-ox resert disinfectant.User facility personnel contacted poison control and elected to proceed with the procedure.A procedure delay was reported.No report of injury.

• Brand Name: REVITAL-OX RESERT DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19564029
• Report Number: 1937531-2024-00003
• Device Sequence Number: 12311414
• Product Code: MED
• UDI-Device Identifier: 00724995095017
• UDI-Public: 00724995095017
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 06/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/18/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown