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

Model Number BIONOVA PCD222-C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

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 Description

During a trial, a bi used inside the pcd test pack gave a positive result.

• Brand Name: BIONOVA
• Type of Device: 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
• MDR Text Key: 331687140
• Report Number: 3013145340-2023-00009
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164676027
• UDI-Public: 07798164676027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1