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

Model Number	IT26-C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a chemical integrator showed ink leaking after the sterilization cycle.
Additional Manufacturer Narrative
According to the distributor, there was no known reportable event that occurred.One indicator showed bleeding of the ink and the user had to reprocess the load.Device malfunction cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness, which could contribute to a serious injury if it were to recur.Additionaly, the ink bleeding from the indicator could stain the sterilizer's load affecting the usability of the processed devices, which could also contribute to a death or serious injury if it were to recur.

• Brand Name: INTEGRON
• 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: 18464257
• Report Number: 3013145340-2024-00012
• Device Sequence Number: 7079223
• Product Code: JOJ
• UDI-Device Identifier: 07798164679622
• UDI-Public: 07798164679622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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
• Device Model Number: IT26-C
• Device Lot Number: B20040
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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