MAUDE Adverse Event Report: TRUE INDICATING LLC STERIM; BIOLOGICAL INDICATOR

Model Number	SRI-050
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when an employee removed the self-contained biological indicator from the incubator, a piece of the activated (crushed) biological indicator vial contacted their face resulting in a scratch.No medical treatment was sought or administered.
Additional Manufacturer Narrative
The device history record was reviewed and confirmed the lot subject of the event was manufactured to specifications.A complaint review was performed and confirmed the reported event to be isolated.The reported event may be attributed to the cap for the biological indicator being loose before it was placed in the incubator.The cap should be tightened after the biological indicator is activated (crushed).Through follow-up, it was stated that user facility personnel utilized a vial crusher to activate the biological indicator; however, the vial crusher is not a steris product and may be incompatible with the self-contained biological indicator subject of the reported event.Steris is the contract manufacturer of the device subject of the event and does not have the user facility contact information.Steris notified the manufacturer, true indicating llc, to provide the investigation results and perform retraining with the user facility.No additional issues have been reported.

• Brand Name: STERIM
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): TRUE INDICATING LLC; 946 kane st; suite a; toledo OH 43612
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer Contact: daniel davy ; 946 kane st; suite a; toledo, OH 43612 ; 4402597401
• MDR Report Key: 23842724
• Report Number: 3004080920-2025-00002
• Device Sequence Number: 13251395
• Product Code: FRC
• UDI-Device Identifier: 00197644080601
• UDI-Public: (01)00197644080601(11)240917(17)260731(10)S012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SRI-050
• Device Catalogue Number: SRI-050
• Device Lot Number: (10)S012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown