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 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

No device-related death or serious injury was reported.Investigation shows there is no malfunction of the auto-reader.The positive readout may have been caused by an ineffective sterilization process.However, although no information of the biological indicator was gathered, there's 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 and, hence, to a serious injury.

Event Description

Sales representative reported malfunctioning of the autoreader incubator because of positive results obtained with the biological indicator after sterilization process in the vp4 equipment.

• Brand Name: STRYKER SRBI30
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18478140
• MDR Text Key: 332991960
• Report Number: 3013145340-2024-00010
• 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: 01/09/2024

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 Operator: Health Professional
• Device Model Number: STRYKER SRBI30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 01/09/2024
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1