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

Catalog Number	60A160
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: k913859 and k083641.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.
Event or Problem Description
It was reported that a portex® bivona® uncuffed adult tracheostomy tube flanges ripped open, which caused the tube to be dislodged at the site where the tracheostomy tube ties were threaded through.The patient was using posey tracheostomy tube ties when the event occurred.It was noted that the patient did not have a history of pulling the tube or manipulating the tube ties, and the ties were not tied tighter than recommended.The device was used for up to one month prior to being sanitized via light rinsing and boiling water up to two times before the failure occurred.The tube was replaced with a new tube.No patient injury was reported.See mfr: 3012307300-2017-00828.

• Brand Name: PORTEX® BIVONA® UNCUFFED ADULT 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: 6477378
• Report Number: 3012307300-2017-00829
• Device Sequence Number: 18984578
• Product Code: JOH
• UDI-Device Identifier: 15021312005554
• UDI-Public: 15021312005554
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: 60A160
• Device Lot Number: 2720352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1