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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dilator of the blue rhino g2-multi percutaneous tracheostomy introducer set, "gives way when dilating" during percutaneous tracheostomy procedures.Additional information regarding patient outcome has been requested, but is currently unavailable.
Additional Manufacturer Narrative
Customer (person): street: (b)(6), phone: (b)(6).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
In additional information received on 19apr2022, it was reported that the customer had been using the device incorrectly.The rep then provided additional training and the use issue with the dilators has been resolved.No specific lot numbers experiencing the issue could be provided.
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: b1, event is no longer a reportable malfunction.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
Additional information was provided on 25may2022 providing further clarification of the customer's incorrect use of the device.It was reported that the physicians had used the loading dilators for dilation.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or product malfunction.As this event is solely the result of user error with no other performance issue, and there have been no related death or serious injuries reported, there will be no additional reports sent for this event.

• Brand Name: BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13668009
• Report Number: 1820334-2022-00343
• Device Sequence Number: 4756369
• Product Code: JOH
• UDI-Device Identifier: 00827002576964
• UDI-Public: (01)00827002576964(17)250106(10)14380759
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2022

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: 01/06/2025
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-100-HC-G-EU-FLEX8.5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 05/25/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/25/2022; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Unknown