MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BIVONA® FLEXTEND¿ TTS¿ PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 67PFSS35

Device Problems Inflation Problem (1310); Leak/Splash (1354); Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

Additional 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.

Event Description

It was reported that the tracheostomy cuff would not inflate and it leaked.The old tracheostomy tube was replaced with the defective tube as part of a weekly routine change.When it was inserted, the ventilator started to alarm.The patient's mother removed the tube and tried to inflate it, but it would not inflate.Sterile water would not go to the balloon from the cuff.It was unknown if cuff patency was checked prior to use.The tube was switched out with another tube in a non-urgent matter.There was no injury associated with the issue.

Manufacturer Narrative

A 3.5mm tts pediatric flextend trach was returned for cuff leak.A visual inspection was performed and a small cut was observed on the balloon area.The cut measured 1/2mm in length.Functional testing was performed using a standard syringe, 5cc's of air was pushed through the inflation line; the cuff did not inflate.System leak test was performed on the device by placing in a pan of water, pushing air through the inflation line, water was observed coming from the balloon.The instruction for use (ifu), states the following: do not use a tube that is cut or damaged.Use of a damaged tube can result in airway compromise.This device must be thoroughly inspected for signs of damage or wear prior to each use.Guard against product damage by avoiding contact with sharp edges.The ifu also recommends the use of twill.The type of trach holder identified in the complaint description, contains a ridged velcro strap that has the potential to cut the eyelet promoting a tear.Root cause is the failure as a result of the customer/ user interfacing with the product in a manner inconsistent with the ifu.(b)(4).

• Brand Name: BIVONA® FLEXTEND¿ TTS¿ PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5815315
• MDR Text Key: 50198346
• Report Number: 2183502-2016-01546
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: 67PFSS35
• Device Lot Number: 3190350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VENTILATOR
• Patient Weight: 10