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

Catalog Number HU16AS40NGE047N

Device Problems Break (1069); Out-Of-Box Failure (2311); Split (2537); Material Integrity Problem (2978)

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that a portex bivona custom hyperflex tracheostomy tube was found broken and split at the flange where the tracheostomy tube tie would attach, upon opening the box.The event occurred in the patient's home with the patient's mother, grandmother, nurse, or registered respiratory therapist present.It was noted that the flange was made of a more slippery silicone.The tracheostomy tube was changed daily and new tubes were exchanged in every 6 months.The patient had to be taken to a pediatric otolaryngologist as the patient was without a proper tracheostomy tube for an unknown amount of time, and was switching with a step-down tracheostomy tube.The patient was treated with antibiotics for two weeks due to irritation from the tracheostomy tube changes.The irritation was resolved once new tracheostomy tubes were received.No permanent injury was reported.

Manufacturer Narrative

One 4.0mm customized tracheostomy tube was returned for investigation.A review of the device history record, relevant to the reported lot, found that the device passed qa inspection prior to shipment.Visual inspection of the device revealed that both flange eyelets were torn completely through.Further inspection of the torn eyelets, found that the tears appeared to be caused by a sharp object.According to the initial reporter's description of the event, velcro neck ties were used to secure the tracheostomy tube during patient use.Per the device instructions for use (dfu), velcro tracheostomy tube holders may have sharp edges which can come into contact with the eyelets and compromise the product integrity.The device instructions for use recommend using the provided twill tape to secure the tracheostomy tube.

• Brand Name: PORTEX® BIVONA® CUSTOM HYPERFLEX¿ 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: 6120408
• MDR Text Key: 60651398
• Report Number: 3012307300-2016-00399
• Device Sequence Number: 1
• Product Code: JOH
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 02/05/2021
• Device Catalogue Number: HU16AS40NGE047N
• Device Lot Number: GS020945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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 Outcome(s): Required Intervention
• Patient Weight: 37