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

Catalog Number 100/897/080CZ

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

This procedure was performed in (b)(6).The therapeutic goods administration (tga) received this report from the reporter; (b)(6) hospital.The portex uniperc tracheostomy tube was used in patients with difficult anatomy.It is a cuffed tube with an inner cannula.They have reported events with similar contributing factors, when staff have used the same process to clean the inner cannula with sterile gauze and forceps threading the gauze through the tube to remove secretions.In this procedure the cleaning process has led to the gauze being left inside the inner cannula after cleaning.The staff were unaware of the gauze which led to staff replacing the inner cannula and the gauze occluding the airway.This situation of leaving gauze in the inner cannula had a patient drop their oxygen saturation.When the tracheostomy inner cannula was removed to check, the error was found and the gauze was removed and the patient made a recovery.

Manufacturer Narrative

No device was returned for product investigation.Based upon the report that was received, it was determined that the root cause of the reported issue was the customer using the device in a manner which was inconsistent from the device instructions for use.(b)(4).

• Brand Name: PORTEX®UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5749304
• MDR Text Key: 48188137
• Report Number: 2183502-2016-01247
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other; Required Intervention