MAUDE Adverse Event Report: BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: manager, equipment & supplies.Pma/510(k) # : k193133.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the tip of the 14fr introducer dilator contained in the blue rhino g2-multi percutaneous tracheostomy introducer tray cracked during use.A second tray was opened to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and device return status have been requested, but is currently unavailable.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This report is being sent to indicate that this event is not reportable.No additional reports will be submitted related to this event.Upon further investigation, this event is not reportable.A review of reporting software for similar events (tip damage of the 14 fr introducer dilator in the blue rhino g2-multi percutaneous tracheostomy introducer tray) does not indicate a previous incident of patient harm from the complaint device or similar devices.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is not reportable as it does not meet the criteria for a death, serious injury or product malfunction.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 11888942
• Report Number: 1820334-2021-01408
• Device Sequence Number: 3223328
• Product Code: JOH
• UDI-Device Identifier: 00827002577046
• UDI-Public: (01)00827002577046(17)220101(10)13839569
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PTISY-100-UNS-HC-G-NA
• Device Lot Number: 13839569
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 08/27/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/01/2021; 09/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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