MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA80
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Information was received indicating that after three days of use a leak was noted with the cuff of this tracheostomy tube.This tracheostomy tube was removed and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One portex® bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube was received for analysis.Visual inspection was performed by the unaided eye and by viewing under magnification.The defect was confirmed, but it was determined not to be the result of a manufacturing issue.It was likely that the tube was contacting a rough spot (e.G., splinters, cartilage, or calcification) on the end user's trachea causing the wear/abraded marks.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode was found to be a cut/puncture of the cuff.The root cause is unknown.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7152672
• Report Number: 3012307300-2017-02708
• Device Sequence Number: 980605
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2022
• Device Catalogue Number: 67HA80
• Device Lot Number: 3407146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention