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

Catalog Number 60A160

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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: 3012307300-2017-00829.

• Brand Name: PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6477384
• MDR Text Key: 72378031
• Report Number: 3012307300-2017-00828
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312005554
• UDI-Public: 15021312005554
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1