MAUDE Adverse Event Report: TERRAGENE S.A. BIONOVA BT220; BIOLOGICAL INDICATOR

Model Number	BIONOVA BT220
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	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse event reported.Most probable cause of the negative results is misuse by the user.
Event or Problem Description
False negative result.Not enough evidence for misuse.

• Brand Name: BIONOVA BT220
• Common Device Name: BIOLOGICAL 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: 19590490
• Report Number: 3013145340-2024-00025
• Device Sequence Number: 11598314
• Product Code: FRC
• UDI-Device Identifier: 07798164670247
• UDI-Public: 07798164670247
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K163646
• 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): 06/21/2024

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 Expiration Date: 12/31/2022
• Device Model Number: BIONOVA BT220
• Device Lot Number: A10028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown