MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60SP040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that, while in use with a patient, the eyelet on the flange of this tracheostomy tube broke during routine tightening of the tracheostomy ties.It was noted that the manufacturer provided twill ties were being used.The tracheostomy tube had to be removed and the patient had to use their emergency backup tracheostomy tube.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One portex® bivona® uncuffed pediatric tracheostomy tube was received for analysis in used condition.Visual inspection was performed at 12" under normal conditions of illumination.It was observed that the sample has a split on the flange eyelet.An attempt to produce the failure by making a small cut in a neckflange eyelet with a blade was performed in two pieces.One piece had the cut on the inside and the other one on the outside.A twill tape cut was used to pull the neckflange by hand; it was possible to reproduce the failure mode.The directions for use (dfu) was reviewed, which give instructions on how to guard against sharp edges.The most probable root cause is that damage occurred after the product left the smiths healthcare facility.

• Brand Name: PORTEX® BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE 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: 7357232
• Report Number: 3012307300-2018-00741
• Device Sequence Number: 2023437
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: No Information
• Device Expiration Date: 07/22/2022
• Device Catalogue Number: 60SP040
• Device Lot Number: 3445561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention