MAUDE Adverse Event Report: STERIS Corporation CELERITY; HP Indicator Tape

Model Number	PCC077
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report #0505900000-2026-8004 that, ¿steris hp indicator tape ref pcc077 hit and missed changing the color after exposure to low temperature sterilization.¿ no report of injury.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification ¿ the lot number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: CELERITY
• Common Device Name: HP Indicator Tape
• Manufacturer (Section D): STERIS Corporation; 6515 hopkins rd; mentor OH 44060
• Manufacturer (Section G): STERIS Corporation; 6515 hopkins rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50818420
• Report Number: 3000251274-2026-00004
• Device Sequence Number: 16114167
• Product Code: JOJ
• UDI-Device Identifier: 00724995231507
• UDI-Public: (01)00724995231507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/18/2026

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: PCC077
• Device Catalogue Number: PCC077
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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