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

Catalog Number	100/897/090CZ
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
User facility reported that a tracheostomy tube cuff failed to maintain sufficient pressure for adequate ventilation on ventilator.Information indicates the cuff balloon deflated as soon as it was pumped up with a pressure manometer.The tracheostomy tube had been in situ for 5 days prior to deploying the cuff.Before removing, the needle indicated the pressure decreased rapidly even while attempting to pump up the cuff.After removal, the manometer showed the same loss of pressure although pressure reduced at a slower rate than when deployed in the trachea.No patient injury was reported.
Additional Manufacturer Narrative
This complaint device is considered to be a life-supporting device, thus is essential to maintaining human life.This file is considered malfunction reportable.There was no serious injury reported.One portex® uniperc® adjustable flange extended-length tracheostomy tube was received for analysis in used condition.Under visual inspection it was noted that the adjustable flange was pulled above the last marking on the tubes resulting in tube inflation system damage.During the manufacturing process, the devices are 100% tested for inflation, which involves inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure.The inflation test was repeated on the sample.After the 12 hour period, the cuff was significantly deflated.The sample was submerged in water and the tracheostomy tube cuff was inflated using a syringe filled with air.Air was observed to be leaking from the place where the inflation line is connected with the inflation lumen.This place was found to be damaged by the adjustable flange, which was pulled above the last marking on the tube.The device history record was reviewed and found to be in compliance with no manufacturing or testing issues found.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7503690
• Report Number: 3012307300-2018-01508
• Device Sequence Number: 11029021
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 3448556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention