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

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.(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 was initially observed by the patient's grandmother and confirmed by a registered respiratory therapist.The tracheostomy tube was changed daily and new tubes were exchanged in every 6 months.It was noted that the flange was made of a more slippery silicone.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.

• 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: 6120425
• MDR Text Key: 60651634
• Report Number: 3012307300-2016-00402
• 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
• 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 Catalogue Number: HU16AS40NGE047N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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