MAUDE Adverse Event Report: SMITHS MEDICAL, INC. BIVONA TTS ADULT ADJUSTABLE NECK FLANGE HYPERFLEX; TRACHEOSTOMY TUBE

Catalog Number 67HA80

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extubate (2402)

Event Date 03/14/2015

Event Type  Injury  

Event Description

User facility reported that the device had been in use for approximately 45 minutes when hospital personnel heard an audible cuff leak occur.A doctor was notified, and water was aspirated from the cuff, then additional water was inserted.Despite the addition of water to the cuff, the doctor decided to replace the entire tracheostomy tue.No further adverse effects to pt reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

• Brand Name: BIVONA TTS ADULT ADJUSTABLE NECK FLANGE HYPERFLEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4759641
• MDR Text Key: 5791337
• Report Number: 2183502-2015-00297
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 67HA80
• Device Lot Number: 2757563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2015
• Distributor Facility Aware Date: 03/14/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other