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

Catalog Number 670170

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported during removal of the cannula, a lack of cuff symmetry had been observed.The lack of symmetric cuff inflation caused poor ventilation of the patient due to significant leakage, which led to the withdrawal of the cannula.It was further reported that a tracheostomy tube change out was successfully performed and there was no injury to the patient.

Manufacturer Narrative

Evaluation results: one bivona tracheostomy tube was returned for investigation.Visual inspection of the device did not reveal any defects.Using a standard syringe, 16cc's of air was inserted into the inflation line.The device measured 12mm with a standard ruler from the center of the shaft to the smaller side of the cuff; it measured 19mm from the larger side of the cuff.Although the cuff may have had appeared asymmetrical, the investigation determined it met the manufacturing specification of 60:40 ratio for tts cuffs.

• Brand Name: PORTEX® BIVONA® TTS ADULT TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7643415
• MDR Text Key: 112516877
• Report Number: 3012307300-2018-02487
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (y/n): N
• PMA/PMN Number: K083641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 670170
• Device Lot Number: 2700209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention