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

Catalog Number 100/890/090CZ

Device Problems Difficult to Insert (1316); Kinked (1339); Obstruction of Flow (2423); Structural Problem (2506)

Patient Problem No Code Available (3191)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.Mfr# clarification: new registration number (b)(4) is now being used for mfr report number, replacing registration number (b)(4).

Event Description

It was reported that a portex uniperc adjustable flange extended-length tracheostomy tube inner cannula was changed for a patient overnight and shortly afterward, the patient had developed difficulty ventilating.A suction catheter could not be passed in the cannula, and the inner cannula was changed.The patient's condition improved after the inner cannula was removed and the nurse cared for the patient.Upon inspection, it was noted that the top of the tube near the pull ring had kinked, which caused obstruction of the patient's airway.The reporter noted the plastic material felt more "lax" and pliable compared to the rest of the tube further down the tube.It was unknown when the tube was first used on the patient.The reporter noted that it was unlikely that it had been in use for more than 28 days.The inner cannula was initially inserted into the tracheostomy tube with no difficulty.No permanent injury was reported.

Manufacturer Narrative

One used 9.0mm portex® uniperc® adjustable flange extended-length tracheostomy tube was returned for investigation.The returned device was received inside a plastic bag without its original packaging.Visual inspection revealed a kink/curve near the blue hub of the device.The wall thickness of the device was then measured and was found to be within specification.Investigation determined that the root cause of the kink/curve was due to the device being used in a manner inconsistent from the instructions for use.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6022974
• MDR Text Key: 57184455
• Report Number: 3012307300-2016-00076
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 100/890/090CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• 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 Age: 67 YR