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 02/16/2024

Event Type  malfunction  

Event Description

The user facility reported that their verify steam integrating indicator leaked in the sterilized set resulting in a procedure delay.

Manufacturer Narrative

Steris has contacted the customer for additional information regarding the reported event.To date, we have not received a response from the customer.A follow-up mdr will be submitted should additional information become available.

• 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: 18993843
• MDR Text Key: 338829162
• Report Number: 3000251274-2024-00002
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: 10724995002104
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCC065
• Device Lot Number: 923B
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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