MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL HENRY SCHEIN; BIOLOGICAL INDICATOR

Model Number	CSBI25HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that an assistant took a self-contained biological indicator ampule/vial out of the sterilizer.She then put it in the incubator.When she cracked or snapped off the top of the ampule, the glass broke, cut her, and the liquid seeped into the incubator causing it to start smoking.Assistant did not need to go to the hospital.
Additional Manufacturer Narrative
Based on the description of the event, the cap came off when being crushed.It is possible that if the person was pushing up on the cap during the crushing process that is why the cap came off.When the ampule/vial comes out of the sterilizer it can be hot and under pressure, it is recommended to wait at least 10 minutes before activating the ampule.The device history record (dhr) was reviewed with no discrepencies noted.No similar complaints have been noted for (b)(6), lot 9072.

• Brand Name: HENRY SCHEIN
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 west henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 19928232
• Report Number: 1319130-2024-00005
• Device Sequence Number: 19544854
• Product Code: FRC
• UDI-Device Identifier: 00304040005149
• UDI-Public: 00304040005149
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 01/31/2026
• Device Model Number: CSBI25HS
• Device Catalogue Number: 1025804
• Device Lot Number: 9072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female