MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC BIVONA ADULT TTS TRACHOSTOMY TUBES; TRACHEOSTOMY TUBE

Catalog Number 750180

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating the device cuff was too porous, causing the cuff to leak while in use with the pt for an unk amount of time.No incident related medical sequela was reported.

Manufacturer Narrative

Manufacturer completed the entire form.Additional manufacturer narrative: customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Manufacturer Narrative

The suspect tracheostomy tube was returned to the manufacturer for evaluation.During functional testing, the cuff was infalted with 10cc of air.The device was then submerged in water.Bubbles were observed escaping from the device cuff.Visual inspection revealed a small cut in the cuff material.No other damages or issues were found with the returned device.Review of the device history record revealed no non-conformities during manufacturing.Manufacturing performs a 100% leak check prior to product release, had the cuff been cut at that time, the leak would have been detected and the device scrapped.No evidence was found to suggest the reported product fault was related to a manufacturing issue; however, the root cause for the damaged cuff could not be determined.(b)(4).

• Brand Name: BIVONA ADULT TTS TRACHOSTOMY TUBES
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD INC; gary IN
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4768302
• MDR Text Key: 5790279
• Report Number: 2183502-2015-00310
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 750180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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