MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM 6.5 A/C STANDARD NS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number CM3162N

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.

Event Description

It was reported that the balloon of a portex® bivona® custom 6.5 a/c standard ns tracheostomy tube was leaking after one week in use.The leak was noticed by a private duty nurse during bedside care.Cuff patency was tested prior to use, and the cuff was filled with air.Velcro tracheostomy tube ties were used to hold the device in place.The nurse changed the tracheostomy tube.No injury was reported, and the event was reported as resolved.

Manufacturer Narrative

One device was returned for evaluation.Functional testing involved leak testing and found no signs of leaking.A review of the device history record found that the lot had no abnormalities and was within specified dimensions.Functional testing involved dimensional testing and found the cuff passed the wall thickness specification.Based on the evidence, a root cause was unable to be confirmed.No fault was found with the device.

• Brand Name: PORTEX® BIVONA® CUSTOM 6.5 A/C STANDARD NS TRACHEOSTOMY TUBE
• 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
• MDR Report Key: 6541807
• MDR Text Key: 74364051
• Report Number: 3012307300-2017-00998
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517038866
• UDI-Public: 15019517038866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: Nurse
• Device Expiration Date: 08/10/2021
• Device Catalogue Number: CM3162N
• Device Lot Number: GS027458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 38