MAUDE Adverse Event Report: COOK INC VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE; BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a versatube¿ tapered tracheostomy tube was placed in a (b)(6) female patient with encephalitis and ventilator associated pneumonia (vap) for approximately one week.As reported, the staff deflated cuff with a syringe and removed the tube from the patient¿s stoma.The user reported ¿deflated cuff on the size 8 versa tube had quite raised folds that felt hard rather than soft making it difficult to pass through the stoma with the raised edge of the folds causing some trauma (bleeding) to the stoma.¿ the bleeding at the stoma site was stopped with applied pressure for 2 minutes.It was reported that the patient did not have any bloody or red tinged secretions prior to removal.The trach stoma was cleaned and the dressing was changed two to three times each day.A cuff manometer was used on the device at the end of the shift and then every four hours.The device was noted to be completely deflated upon removal.No other adverse effects were reported for this incident.

Manufacturer Narrative

Additional information: d10 ¿ product received on 02apr2019.H6 ¿ results code: appropriate term/code not available (4247) - bleeding.Investigation - evaluation a review of the drawing, instructions for use, quality control, as well as a visual inspection of the returned device was conducted during the investigation.One device was returned to the manufacturer for investigation.A visual examination noted that the device was returned with the air vacuum out of the balloon.Creases were noted in the balloon material and could also be manually felt.Additionally, a document-based investigation evaluation was performed.It was determined that there are sufficient manufacturing controls and inspection activities to identify this failure prior to the device distribution.A review of the device history record could not be completed, as the lot information is unknown.There is no evidence indicating that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings cuff pressures should be monitored and adjusted routinely and should never exceed 25mm hg.Over-inflation of the cuff may inhibit ventilation and may also result in permanent damage to the trachea, underinflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.Verify tracheostomy tube position via bronchoscopic visualization and/or chest x-rat to ensure correct placement.Incorrect placement may result in partial or total airway obstruction.Precautions this product is designed to be used in percutaneous dilational tracheostomy (pdt) procedures and balloon assisted tracheostomy procedures.Standard pdt or balloon assisted tracheostomy techniques should be employed.Sterile technique should be adhered to for the handling and insertion of the tracheostomy tube.The versa tube tracheostomy tube is classified as a single use device.The manufacturer recommends that the tracheostomy tube usage does not exceed twenty-nine days.The inner cannula should be checked and replaced at regular intervals to avoid blockage which may reduce or obstruct airway lumen.Do not reposition the in-situ tracheostomy tube while the cuff is inflated; doing so may result in trauma to the stoma and/or trachea during anesthesia, nitrous oxide may diffuse into the cuff, causing an initial increase, with subsequent decrease, in cuff pressure.This can result in pressure trauma to the trachea and loss of airway seal, resulting in aspiration of subglottic secretions into the lungs.Prior to removal of cuffed tracheostomy tubes, ensure that all air is completely removed from the cuff; failing to do so may result in pain to the patient and damage to the trachea and/or stoma.Instructions for use tube preparation 4.Ensure that the cuff is fully deflated.Insertion 9.Inflate the low-pressure cuff by injecting air into the luer valve of the inflation line using a syringe.Selection of a cuff inflation and deflation method is at the discretion of the physician/hospital.Cuff deflation and tube removal 12.Before removing the tube, the cuff should be completely deflated.This will ensure that the cuff passes through the stoma with minimal resistance.Note: accumulated secretions above the cuff may need to be suctioned before deflating the cuff (with a syringe), unless suctioning is contraindicated.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a definitive root cause could not be established.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and we 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 Description

No new event description information to report at this time.

• Brand Name: VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE
• Type of Device: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8445215
• MDR Text Key: 139677187
• Report Number: 1820334-2019-00684
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K100283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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-VT-8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 58