MAUDE Adverse Event Report: TERRAGENE S.A. VERISURE; CHEMICAL INDICATOR

Model Number	VERISURE STEAM TYPE 5 MIGRATING INTEGRATOR W/ EXTENDER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the batch's device history record showed no anomalies.The retention sample from the reported batch was inspected finding that it was released in acceptable condition.To further support the evaluation, we tested the retained samples to try to replicate the conditions reported by the customer.Terragene found no loss of structural integrity, no seal compromise, and no anomalies in ink performance or label adhesion.The results obtained by the customer could not be replicated.No report of injury or delays in the process.No additional issues were reported.
Event or Problem Description
The customer reports that they used an verisure¿ steam type 5 migrating integrator w/ extender (73155) and, after sterilization, observed ink leakage (bleeding).

• Brand Name: VERISURE
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional no. 9 km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 23030773
• Report Number: 3013145340-2025-00002
• Device Sequence Number: 15848462
• Product Code: JOJ
• UDI-Device Identifier: 07798375772259
• UDI-Public: (01)07798375772259(17)291130(10)B40587
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: VERISURE STEAM TYPE 5 MIGRATING INTEGRATOR W/ EXTENDER
• Device Catalogue Number: 73155
• Device Lot Number: B40587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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