MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SRBI30; 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 07/11/2022

Event Type  malfunction  

Event Description

According to the user, the auto-reader incubator kept showing positive results for the biological indicators after the sterilization process.

Manufacturer Narrative

No device-related deaths or serious injuries were informed and there is no objective evidence of product malfuction.However, as no further information was provided, we consider the positive readout may have been caused by an ineffective sterilization process or a biological indicator malfunction, which may cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness.This could contribute to delay patient treatment and, hence, to a serious injury if it were to recur.

• Brand Name: STRYKER SRBI30
• 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: 18482956
• MDR Text Key: 332545500
• Report Number: 3013145340-2024-00023
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678793
• UDI-Public: 07798164678793
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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 Model Number: STRYKER SRBI30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1