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 Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: inventory coordinator g4 ¿ 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.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.
Event or Problem Description
It was reported that two blue rhino g2-multi percutaneous tracheostomy introducer sets experienced bending of the "blue dilators" during a case.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported that two blue rhino g2-multi percutaneous tracheostomy introducer sets experienced bending of the "blue dilators" during a case.It is unknown if there were any adverse effects to the patient due to this event.Additional information regarding the event and patient outcome was requested but was not supplied.Reviews of the complaint history, device history record, instructions for use, 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.A document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record for the reported lot and records no relevant non-conformances.A search on the sub assembly lots found no non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The product ifu, [c_t_ptisgi2_rev0] ¿blue rhino g2-multi percutaneous tracheostomy introducer,¿ provides the following information to the user related to the reported failure mode: warnings ¿improper dilation technique or tracheostomy tube placement can lead to delayed complications.Anatomic anomalies may make the procedure difficult to perform.¿ precautions ¿bronchoscopic guidance is strongly recommended during placement of this device to reduce the likelihood of paratracheal insertion and to determine the intratracheal position of the needle, wire guide, dilators and tracheostomy tube.An ultrasound evaluation of the patient¿s neck prior to the procedure may aid in identification of anatomical variances.¿ instructions for use patient preparation ¿2.Place the patient in the tracheostomy position.¿ tracheostomy procedure ¿1.Palpate landmark structures (thyroid notch, cricoid cartilage) to ascertain proper location for tracheostomy tube placement.Access and , ultimately, tube placement is ideally made at the level between the first and second tracheal cartilages or between the second and third tracheal cartilages whenever feasible.3.If desired, use a curved mosquito clamp to gently dissect vertically and transversely down to the anterior tracheal wall.With a finger tip, dissect the front of the trachea, in the midline, free of any tissues and identify the cricoid cartilage.Displace the isthmus of the thyroid downward, if present.Note: an adequate skin incision and blunt dissection of the subcutaneous tissue can minimize the need for excessive force and torque throughout the procedure.Excessive force and torque may lead to long-term complications.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 building catheter as a unit over the wire guide, while maintaining wire guide position.15.Begin to dilate the tracheal access site by advancing the building 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, advance them as a unit to the skin level mark on the blue rhino g2-multi dilator.Note: proper positioning and alignment may help minimize complications.¿ how supplied ¿¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of product labeling and device history record does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no device return, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The customer did not clarify which component was bending.It is possible patient anatomy contributed to the failure.However, none of these possibilities can be confirmed without additional information and/or physical examination of the complaint device.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.

• 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: 18530269
• Report Number: 1820334-2024-00086
• Device Sequence Number: 12687198
• Product Code: JOH
• UDI-Device Identifier: 00827002576827
• UDI-Public: (01)00827002576827(17)260201(10)15551006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: 02/01/2026
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-100-HC-G-NA
• Device Lot Number: 15551006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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