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

Model Number	G57686
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blue rhino dilator from a blue rhino g2-multi percutaneous tracheostomy introducer set experienced difficulty during the procedure due to bends on the device.The procedure was successfully completed by using a new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
E1 - phone number: (b)(6).H3 - device evaluated by mfg.? device not returned to manufacturer.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the blue rhino dilator from a blue rhino g2-multi percutaneous tracheostomy introducer set experienced difficulty during the procedure due to bends on the device.The procedure was successfully completed by using a new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot and the related subassembly lot did not reveal any quality control discrepancies.A complaint history search identified no other complaints under this lot number at the time of this investigation.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ptisgi_rev0]¿ blue rhino g2-multi percutaneous tracheostomy introducer,¿ provides the following information for the user: instructions for use tracheostomy procedure: 1.Palpate landmark structures (thyroid notch, cricoid cartilage) to ascertain proper location for tracheostomy tube placement.3.If desired, use a curved mosquito clamp to gently dissect vertically and transversely down to the anterior tracheal wall.Note: an adequate skin incision and blunt dissection of the subcutaneous tissue can minimize the need for excessive force and torque throughout the procedure.13.Activate the hydrophilic coating by immersing the distal end of the blue rhino g2-multi dilator in sterile water or saline.14.Advance the blue rhino g2-multi dilator and the guiding catheter as a unit over the wire guide, while maintaining wire guide position.15.Begin to dilate the tracheal access site by advancing the guiding catheter and blue rhino g2-multi dilator into the trachea.While maintaining the visual reference points and positioning relationships of the wire guide, guiding catheter and dilator, advancing them as a unit to the skin level mark on the blue rhino g2-multi dilator.¿ based on the information provided, no returned product, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 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: 22884879
• Report Number: 1820334-2025-01057
• Device Sequence Number: 4849404
• Product Code: JOH
• UDI-Device Identifier: 00827002576865
• UDI-Public: (01)00827002576865(17)271001(10)16501027
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K193133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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 Model Number: G57686
• Device Catalogue Number: C-PTIS-100-UNS-HC-G-EU
• Device Lot Number: 16501027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 62 KG