MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR; BIOLOGICAL INIDICATOR

Model Number	SCS-106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced inhalation/irritation and became unconscious after breaking a sporview self-contained biological indicator.The user facility did not disclose if medical treatment was sought or administered.
Additional Manufacturer Narrative
Crosstex has contacted the customer to obtain additional information regarding the reported event; however, to date we have not received additional information.The bi media is trypiticase soy broth (tsb) and is non-toxic.The sporview self-contained biological indicator instructions for use states, "caution: after processing the bi is hot and under pressure.Always allow to cool for ten (10) minutes before crushing.Activate the processed bi within 8 hours after processing by gently crushing the inner glass media tube using a vial crusher." a complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR
• Common Device Name: BIOLOGICAL INIDICATOR
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: daniel davy ; 6789 w henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 15259220
• Report Number: 1319130-2022-00004
• Device Sequence Number: 5746013
• Product Code: FRC
• UDI-Device Identifier: 10732224721238
• UDI-Public: 10732224721238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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
• Device Model Number: SCS-106
• Device Catalogue Number: SCS-106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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