MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. MCKESSON; INDICATOR, BIOLOGICAL STEAM SL

Model Number	73-SCS025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for 73-scs025, lot 9104.Instructions state, "caution: after processing, the bi is hot and under pressure.Always allow to cool for ten (10) minutes before crushing.Failure to do so could cause the glass ampule inside the bi vial to burst which may result in injury.".
Event or Problem Description
Dealer/distributor reported that customer stated 2 vials from the same box exploded in their hand when cracking them open.

• Brand Name: MCKESSON
• Common Device Name: INDICATOR, BIOLOGICAL STEAM SL
• 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: 23305061
• Report Number: 1319130-2025-00007
• Device Sequence Number: 9980461
• Product Code: FRC
• UDI-Device Identifier: 20612479159130
• UDI-Public: (01)20612479159130
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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 Model Number: 73-SCS025
• Device Lot Number: 9104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• 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