MAUDE Adverse Event Report: CROSSTEX SPS MEDICAL HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST; BIOLOGICAL INDICATOR

Model Number IMS-1373

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported a dental assistant was using a biological indicator (bi) when the vial burst, resulting in glass shattering near the dental assistant's face.There is potential her eye was exposed to the contents of the vial and glass.After the bi burst, the dental assistant flushed her eyes and sought medical attention to ensure no glass particles were in her eye.She is reported to be doing fine and no additional eye irritation has been reported.Regulatory affairs made several attempts to contact the facility and was unable to confirm the details of the incident or if the user was wearing proper protective equipment during the event.The instructions for use instruct waiting 10 minutes after the vial is removed from the autoclave before activation to ensure the vial has cooled down.It is unknown if the user followed this instruction.The facility did not send product back for investigation.Crosstex sps medical quality assurance team tested 30 vials from the same lot number and could not reproduce the incident reported by the facility.This will continue to be monitored in the crosstex sps medical complaint handling system.

Event Description

The facility reported a dental assistant was using a biological indicator (bi) when the vial burst, resulting in glass shattering near the dental assistant's face.There is potential her eye was exposed to the contents of the vial and glass.

• Brand Name: HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): CROSSTEX SPS MEDICAL; 31 water street #1; cuba NY 14727
• Manufacturer (Section G): CROSSTEX SPS MEDICAL; 31 water street #1; cuba NY 14727
• Manufacturer Contact: lauren johnson ; 31 water street #1; cuba, NY 14727
• MDR Report Key: 8436732
• MDR Text Key: 139335709
• Report Number: 1319130-2019-00001
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: IMS-1373
• Device Catalogue Number: IMS-1373
• Device Lot Number: 6743
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other