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

Model Number	G57721
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation: system clinical manager of value analysis.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.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
It was reported that the hemostat included in blue rhino g2-multi percutaneous tracheostomy introducer tray broke instantly at the time of use.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding event details and patient outcome has 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
Additional information was provided (b)(6) 2024.The product regarding this complaint did come into contact with the patient.Patient information was not able to be provided.The patient¿s condition for requiring treatment was unknown.The procedure was completed by using another like clamp device the patient did not require any additional interventions/procedures nor experience any adverse effects due to this event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the hemostat included in blue rhino g2-multi percutaneous tracheostomy introducer tray broke instantly at the time of use.The device did come into contact with the patient.Patient information was not provided.The patient¿s condition for requiring treatment was unknown.The procedure was completed by using another clamp device.The patient did not require any additional interventions/procedures nor experience any adverse effects due to this event.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One hemostat was returned for evaluation.A visual inspection of the device confirmed breakage.Additionally, 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 device history record (dhr) for the reported complaint device lot and the related subassembly lots revealed no related non-conformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.The affected component is supplied to cook and a supplier investigation was requested.The supplier did not identify any non-conforming material.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: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." evidence gathered upon review of dmr, product labeling, dhr, and device failure analysis, 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 TRAY
• 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: 20472784
• Report Number: 1820334-2024-01345
• Device Sequence Number: 20740557
• Product Code: JOH
• UDI-Device Identifier: 00827002577213
• UDI-Public: (01)00827002577213(17)241005(10)14229763
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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: 10/05/2024
• Device Model Number: G57721
• Device Catalogue Number: C-PTISYJ-100-HC-G-NA-FLEX8.5
• Device Lot Number: 14229763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 05/29/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/08/2024; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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
• Patient Sex: Unknown