MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS VERIFY STEAM INTEGRATING INDICATOR; CHEMICAL INDICATOR

Model Number PCC065

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The verify steam integrating indicator subject of the reported event has been returned to steris for evaluation.The instructions for use states, "the integrator demonstrates passing results when the bar has completely travelled through the "reject" area or window and has entered the "accept" area or window.Variability in the color of the bar is normal and acceptable as long as the bar is visible in the "accept" area or window." investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that their verify steam integrating indicator did not "change in color" subsequently resulting in a procedure delay to occur.No report of injury.

Manufacturer Narrative

The verify steam integrating indicator subject of the reported event was sent back for evaluation.Evaluation results confirmed that the wicking strip within the verify steam integrating indicator was not present.A complaint review confirms this to be an isolated event.Steris will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: VERIFY STEAM INTEGRATING INDICATOR
• Type of Device: CHEMICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18505597
• MDR Text Key: 333316713
• Report Number: 3000251274-2024-00001
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: 10724995002104
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PCC065
• Device Lot Number: 823
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1