MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SRBI30F; BIOLOGICAL INDICATOR

Model Number STRYKER SRBI30

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

No device-related deaths or serious injuries were informed.Device malfunction cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness, since it would not be able to process biological indicators.If this were to recur, the lack of biological indicators processing could affect the load release, which could contribute to a serious injury due to lack of sterile material if it were to recur.

Event Description

The distributor reported the biological indicator is showing positive results after the sterilization proceses, not allowing the loads to be released.

• Brand Name: STRYKER SRBI30F
• Type of Device: 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: 18477203
• MDR Text Key: 332982916
• Report Number: 3013145340-2024-00015
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678793
• UDI-Public: 07798164678793
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

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: 09/30/2023
• Device Model Number: STRYKER SRBI30
• Device Lot Number: A10531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1