MAUDE Adverse Event Report: TERRAGENE S.A. INTEGRON IT26-C; CHEMICAL INDICATOR

Model Number	INTEGRON 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	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no report of infection, injury or harm to patients.Retain testing was performed on the lot number subject of the reported event; the results obtained by the user could not be replicated.The lot performed as established.The dhr for the subject lot was reviewed and no abnormalities were found.
Event or Problem Description
User facility informed that the integron it26-c burst after a complete sterilization cycle.

• Brand Name: INTEGRON IT26-C
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 20180306
• Report Number: 3013145340-2024-00027
• Device Sequence Number: 8261393
• Product Code: JOJ
• UDI-Device Identifier: 07798164679622
• UDI-Public: 07798164679622
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/10/2024

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 Expiration Date: 08/31/2024
• Device Model Number: INTEGRON IT26-C
• Device Lot Number: 19039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2019
• 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