MAUDE Adverse Event Report: TERRAGENE S.A BIONOVA; PROCESS CHALLENGE DEVICE (PCD)

Model Number	BIONOVA PCD222-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	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Positive results on the bi after the sterilization process.No device-related deaths or serious injuries were informed, since it happened during a trial.Potential device malfunction, which may cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness which could contribute to delay patient treatment and, hence, to a serious injury, if it were to recur.
Event or Problem Description
During a trial, a bi used inside the pcd test pack gave a positive result.

• Brand Name: BIONOVA
• Common Device Name: PROCESS CHALLENGE DEVICE (PCD)
• 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: 18399056
• Report Number: 3013145340-2023-00009
• Device Sequence Number: 14128064
• Product Code: FRC
• UDI-Device Identifier: 07798164676027
• UDI-Public: 07798164676027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163646
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: 10/31/2023
• Device Model Number: BIONOVA PCD222-C
• Device Lot Number: F10083
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2021
• 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