MAUDE Adverse Event Report: CROSSTEX SPS MEDICAL CONFIRM 10 BIOLOGICAL INDICATORS

Model Number	C10BULK01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported a dental assistant was injured while using crosstex confirm 10 biological indicators.It was reported the ampoule burst, resulting in liquid splashing onto and scratching the dental assistant's face.After the ampoule burst, the dental assistant flushed eyes and sought medical attention to ensure no additional glass particles remained in the eye.The affected personnel was released without any issues being found.The product instructions for use (ifu) state ten minutes is required between the removal of the bi from the sterilizer to the breakage of the ampoule.The bi was taken directly from the sterilizer and the ampoule was immediately broken, resulting in the burst of the ampoule, thus a failure to follow instructions.The liquid within the bi which splashed in the affected personnel's eye is non-pathogenic.Thus, there is no user risk of eye infection from the media contained in the ampoule.The facility reported there was no product malfunction, and the event was a result of user error in breaking the ampoule immediately after removing from the sterilizer.A lot number of the confirm 10 biological indicators was not provided for this incident.It was reported the dental assistant had been trained on the product ifu and was an experienced user.It is confirmed the affected personnel was not wearing the proper personal protective equipment during use of the bi.This complaint will continue to be monitored in the crosstex sps medical complaint handling system.Facility information: (b)(6).
Event or Problem Description
The facility reported a dental assistant was injured while using crosstex confirm 10 biological indicators.It was reported the ampoule burst, resulting in liquid splashing onto and scratching the dental assistant's face.After the ampoule burst, the dental assistant flushed her eyes and sought medical attention to ensure no additional glass particles remained in her eye.The affected personnel was released without any issues being found.

• Brand Name: CONFIRM 10 BIOLOGICAL INDICATORS
• Common Device Name: BIOLOGICAL INDICATOR
• Manufacturer (Section D): CROSSTEX SPS MEDICAL; 6789 west henrietta rd.; rush NY 14543
• MDR Report Key: 7496816
• Report Number: 1319130-2018-00001
• Device Sequence Number: 1313926
• Product Code: FRC
• UDI-Device Identifier: 10732224000463
• UDI-Public: 10732224000463
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K971432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: Dental Assistant
• Device Model Number: C10BULK01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other