MAUDE Adverse Event Report: TERRAGENE S.A STRYKER; 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 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

No device-related deaths or serious injuries were informed.The positive readout may have been caused by an ineffective sterilization process.However, since no further investigation was made, there is a possibility of a 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.

Event Description

Customer at (b)(6) clinic experience a positive bi.

• Brand Name: STRYKER
• Type of Device: BIOLOGICAL INDICATOR
• 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: 18401393
• MDR Text Key: 331676883
• Report Number: 3013145340-2023-00010
• 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 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 Model Number: STRYKER SRBI30
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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