MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. COFIRM 10 STEAM BIOLOGICAL INDICATORS

Model Number	C10BI25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for c10bi25, lot: 2395.
Event or Problem Description
Office manager reported a bi vial exploded as an assistant removed it from the incubator.The vial was cold.Pieces of glass scratched her face.

• Brand Name: COFIRM 10 STEAM BIOLOGICAL INDICATORS
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w. henrietta rd.; rush, NY 14543
• MDR Report Key: 23707665
• Report Number: 1319130-2025-00011
• Device Sequence Number: 21514427
• Product Code: FRC
• UDI-Device Identifier: 10732224000463
• UDI-Public: (01)10732224000463
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: C10BI25
• Device Catalogue Number: C10BI25
• Device Lot Number: 2395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female