MAUDE Adverse Event Report: TERRAGENE S.A STRIKER; 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 12/13/2022

Event Type  malfunction  

Event Description

It was reported that there were recurring bis failing following completed vp4 cycles.The vp4 did not register any error codes or cancel any loads.

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.

• Brand Name: STRIKER
• 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: 18467518
• MDR Text Key: 332980193
• Report Number: 3013145340-2024-00013
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678793
• UDI-Public: 07798164678793
• Combination Product (y/n): N
• 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: 01/08/2024

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 Model Number: STRYKER SRBI30
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/08/2024
• 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