MAUDE Adverse Event Report: TERRAGENE S.A. BIONOVA IT26-C; CHEMICAL INTEGRATOR

Model Number	BIONOVA 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	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device-related deaths or serious injuries were informed.The malfunction is related to the absence of the pill in that particular chemical integrator.This affects the use of the product and cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness, as it may delay the release of a sterilization load, which could contribute to death or serious injury if it were to recur.
Event or Problem Description
User reported the chemical integrator was not reacting to the sterilization cycle, as it was not showing change of color in the bar.

• Brand Name: BIONOVA IT26-C
• Common Device Name: CHEMICAL INTEGRATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18465663
• Report Number: 3013145340-2024-00011
• Device Sequence Number: 17908995
• Product Code: JOJ
• UDI-Device Identifier: 07798164679622
• UDI-Public: 07798164679622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Other Health Care 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
• Operator of Device: Health Professional
• Device Model Number: BIONOVA IT26-C
• Device Lot Number: B10625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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