MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 65SP035

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2017.Pma/510(k) number: k944178 and k083641.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.

Event Description

It was reported that a portex® bivona® aire-cuf® neonatal and pediatric tracheostomy tube air in the cuff decreased to half-capacity 6 hours after initial use with a patient.The issue was observed by medical personnel.It was unknown if the tube had been checked prior to use.The tracheostomy tube was replaced with a new one.No patient injury was reported.

Manufacturer Narrative

One bivona® 3.5mm aire-cuf® neonatal and pediatric tracheostomy tube was returned for investigation.During functional testing, a syringe was used to inflate the device cuff and inflation balloon with 5cc's of air and the device was submerged under water; the device was manipulated while under the water.No bubbles (indicating a leak) were found escaping from the device.The cuff was removed from the water and the device cuff was inflated with 5cc's of air and allowed to sit for 4 hours.A loss of volume of the cuff was observed; however, a leak could not be detected.Investigation was unable to determine the root cause of the reported issue; however, no evidence was found to suggest a manufacturing defect.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6439277
• MDR Text Key: 71048831
• Report Number: 3012307300-2017-00767
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000290
• UDI-Public: 15021312000290
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 65SP035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1