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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Increased Respiratory Rate (2486); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/16/2022

Event Type  Injury  

Event Description

As reported in a retrospective, observational, post-market study, a 25-year-old female patient had a left lower lobe infiltrate following a tracheostomy placement procedure.On (b)(6) 2022 (1-day post-procedure), the patient had a left lower lobe infiltrate identified on chest x-ray.The site noted, ¿at the time, patient was afebrile and without leukocytosis.It was unclear whether this represented some degree of aspiration from tracheostomy placement or an evolving pneumonia.¿ the patient then developed a fever and leukocytosis.She also developed tachypnea (present at baseline, but increased) and required frequent suctioning, which contributed to the concern for developing pneumonia.Fio2 requirements were increased on (b)(6) 2022.The patient was started on iv vancomycin and zosyn for suspected hospital-acquired pneumonia, but the culture ultimately came back with normal oral flora.It should also be noted that the site determined that the event was not considered related to the blue rhino device, but that the event was considered related to the study procedure.The patient completed her course of antibiotics on (b)(6) 2022, and no additional adverse effects were reported for the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3- occupation: principal investigator.G4- pma/510(k) #: k193133.H6-annex e code unavailable: required frequent suctioning.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that a patient had a left lower lobe infiltrate following a tracheostomy placement procedure with a blue rhino g2-multi percutaneous tracheostomy introducer set.The device was placed due to acute respiratory insufficiency related to traumatic brain injury.On (b)(6) 2022 (1-day post-procedure), the patient had a left lower lobe infiltrate identified on chest x-ray.At this time, it was noted the patient was without fever and without elevated white blood cells.It is unclear if the infiltrate represented some degree of aspiration from tracheostomy placement or an evolving pneumonia.Later, the patient developed a fever, elevated white blood cells, and increased heart rate (present at baseline, but increased).She also required frequent suctioning, which contributed to the concern for developing pneumonia.Fio2 requirements were increased on (b)(6) 2022.The patient was started on intravenous (iv) antibiotics for suspected hospital-acquired pneumonia, but the culture ultimately came back with normal oral flora.The patient completed her course of antibiotics on (b)(6) 2022, and no additional adverse effects were reported.Reviews of quality control and instructions for use (ifu), 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 any potential non-conformances prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.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 most recent instructions for use (ifu) [c_t_ptisg2_rev0] packaged with the device contains the following in relation to the reported failure mode: ¿contraindications: unstable cervical spine fracture.Instructions for use: patient preparation: 2.Place the patient in the tracheostomy position.(fig.4) position a pillow under the shoulders to permit full extension of head and neck.The head of the patient¿s bed may be elevated 30-40 degrees at the physician's discretion.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded that adverse event related to procedure is the cause of this event.It is possible the patient's injury prohibited them from being placed in the tracheostomy position, but cook can not confirm this without more information.It was noted that the site determined that the event was not related to the blue rhino 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
• Type of Device: 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: 17273365
• MDR Text Key: 318566686
• Report Number: 1820334-2023-00871
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-100-HC-G-NA-FLEX7.5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 84 KG