MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020)

Event Date 04/06/2018

Event Type  Injury  

Event Description

It was reported that after being weaned off ventilator support, the patient had the tracheostomy tube in place with the cuff still inflated.The patient was receiving supplemental oxygen delivered by a non-smiths medical tracheostomy mask.While using the two products together, the patient became sweaty and dyspneic.The patient's oxygen saturation levels were observed at 60%.Upon further observation, it appeared that the mask was occluding the end of the tracheostomy tube.The mask was repositioned, and on suctioning, evidence of pulmonary edema was found.The patient required bag ventilation for approximately five minutes, and positive pressure ventilation for 36 hours.The event was reported as being resolved.No permanent injury was reported.

Manufacturer Narrative

The investigation of this complaint was done based on received photo because no sample was received.On the photo there is shown uniperc tracheostomy tube in use with oxygen mask (not part of our finish good kit).The uniperc device is designed to be connected with breathing circuit by 15mm connector as described in instruction for use lls10001024-001 rev.100, page 4: "bonded 15mm connector for connection to the breathing circuit is located on the tube not the inner cannula ensuring the ability to ventilate the patient at all times." based on received complaint description and photo it is deemed that the failure is a result of the customer/user interfacing with the product in a manner inconsistent with the ifu because uniperc tube was not properly connected to breathing circuit.

Manufacturer Narrative

The investigation of this complaint was done based on received photo because no sample was received.On the photo there is shown uniperc tracheostomy tube in use with oxygen mask (not part of our finish good kit).The uniperc device is designed to be connected with breathing circuit by 15mm connector as described in instruction for use lls10001024-001 rev.100, page 4: "bonded 15mm connector for connection to the breathing circuit is located on the tube not the inner cannula ensuring the ability to ventilate the patient at all times." based on received complaint description and photo it is deemed that the failure is a result of the customer/user interfacing with the product in a manner inconsistent with the ifu because uniperc tube was not properly connected to breathing circuit.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7546708
• MDR Text Key: 109351632
• Report Number: 3012307300-2018-01687
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2018
• Patient Sequence Number: 1
• Treatment: HUDSON TRACHEOSTOMY MASK
• Patient Outcome(s): Required Intervention