MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SP045
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that a portex® bivona® uncuffed neonatal and pediatric tracheostomy tube had a cut in the flange's hole.This incident was observed by hospital personnel during use when there was an attempt to replace the tracheostomy tube holder.The cuff had been filled with air and a competitor's holder had been used.It was unknown if the neck holder had to be adjusted at any time.The tracheostomy tube was replaced with a new tube.No patient injury was reported.
Additional Manufacturer Narrative
One portex® bivona® uncuffed neonatal and pediatric tracheostomy tube was returned for investigation.Visual inspection of the returned device revealed black marks/damage at the junction of the plastic silicone.Additionally, secretions were observed on the device shaft inner diameter and between the junction of the plastic and silicone material.Examination of the device eyelets found that nether eyelet had torn completely through; however, if pressure was applied to the eyelet, cut/tears could be observed.During functional testing, a pull test was conducted on both eyelets and both were found to be within specification.It was reported that the tracheostomy tube was held in place with a competitor's tracheostomy tube holder.Investigation determined that the root cause of the observed device issue was due to the use of the device in a manner inconsistent with the device instructions for use.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6312309
• Report Number: 3012307300-2017-00325
• Device Sequence Number: 648102
• Product Code: BTO
• UDI-Device Identifier: 15021312000399
• UDI-Public: 15021312000399
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60SP045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1