MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. SPORVIEW SELF-CONTAINED STEAM BI; BIOLOGICAL INDICATOR

Model Number	SCS-025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for scs-025, lot 9102.Potential root cause, the vial was crushed without the proper 10 min cooling time.The caps are tight on the ampule, also the ampules that come out of the sterilizer can be hot and under pressure, it is recommended to wait at least 10 minutes before activating the ampule.Not a manufacturing defect.
Event or Problem Description
Customer reported nurse was removing the vial from the sterilizer.When she went to crush the vial, it exploded and the vial contents splashed on to her skin, goggles, and clothing, with a piece of glass hitting her cheek.

• Brand Name: SPORVIEW SELF-CONTAINED STEAM BI
• 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 ; 8472574500
• MDR Report Key: 23568889
• Report Number: 1319130-2025-00010
• Device Sequence Number: 13294154
• Product Code: FRC
• UDI-Device Identifier: 10732224720118
• UDI-Public: (01)10732224720118
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 09/30/2026
• Device Model Number: SCS-025
• Device Catalogue Number: SCS-025
• Device Lot Number: 9102
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown