MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SRBI30; BIOLOGICAL INDICATOR

Model Number	STRYKER SRBI30
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	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of an adverse event or product malfuction.The positive readout may have been caused by an ineffective sterilization process.The bis subject of the reported event were discarded and were not available for evaluation.Without the evaluation of the subject indicators, a root cause cannot be determined.There is a possibility of bi 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.
Event or Problem Description
A hospital reported that there were three positive bis after a complete sterilization process.Clinical requested the customer to run an empty cycle with just the bi (for validation purposes) and the bi resulted positive.There's a possibility of bi malfunction, which may cause the delay in patient treatment.

• Brand Name: STRYKER SRBI30
• 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: 18392584
• Report Number: 3013145340-2023-00001
• Device Sequence Number: 21013573
• Product Code: FRC
• UDI-Device Identifier: 07798164678793
• UDI-Public: 07798164678793
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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: 12/31/2022
• Device Model Number: STRYKER SRBI30
• Device Lot Number: RHN122022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2020
• 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