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

Catalog Number 670170

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354)

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

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

The 510(k): k913859 and k083641.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 initially reported that a bivona® adult tts¿ tracheostomy tube had its balloon fail during use.The reporter clarified that the cuff was deflated and leaked, which occurred while the patient was sitting in their power wheelchair doing no activity.This event occurred within a week after placement.The cuff was observed to have many pinholes and leaks.A cuff patency check was observed by a respiratory therapist and it was confirmed that it functioned with no leaks.The husband of the patient heard audible sounds from the patient "as if air was leaking from around the cuff," and he stated that audible coughing was only heard when cuff ruptured and water leaked out.The husband observed multiple leaks upon taking out the tracheostomy tube; he stated there were no pinholes on the cuff, water leaked from the top of the cuff, and the "seam" where the cuff meets the shaft detached as if there was not enough adhesive to seal and hold the cuff down.When the husband injected water into the pilot balloon, water shot out of the cuff and up through the tracheostomy tube.The husband noted he does not check cuff patency prior to insertion.Tracheostomy tube was placed by husband by taking the tube out of the sterile container, lubricating the tube and cuff with ky jelly, and intubating the tube.These steps were done since (b)(6) 2016.An emergent tracheostomy change was required as the cuff would not hold water.No patient injury was reported.

Manufacturer Narrative

One used 7.0mm tts¿ adult tracheostomy tube was returned for investigation.The device was returned with 2 additional tracheostomy tubes.During functional testing, 14cc's of air was inserted into the device and a small leak was detected in the cuff.Using magnification the cut was examined and a tiny abraded area was observed.No evidence was found of the cuff detaching from the shaft.Investigation was unable to determine the root cause of the cut on the cuff; however, no evidence was found to indicate a manufacturing defect.(b)(4).

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5940516
• MDR Text Key: 54364015
• Report Number: 2183502-2016-01945
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 670170
• Device Lot Number: 3136486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR