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

Model Number C10BULK01

Device Problem Material Fragmentation (1261)

Patient Problem Chemical Exposure (2570)

Event Date 04/09/2018

Event Type  Injury  

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 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
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): CROSSTEX SPS MEDICAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX SPS MEDICAL; 6789 west henrietta rd,; rush NY 14543
• Manufacturer Contact: lauren johnson ; 10 ranick rd; hauppauge, NY 11788 ; 6315826777
• MDR Report Key: 7496816
• MDR Text Key: 107687686
• Report Number: 1319130-2018-00001
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10732224000463
• UDI-Public: 10732224000463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 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
• Device Operator: Dental Assistant
• Device Model Number: C10BULK01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other