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

Catalog Number	60SP040
Medical Device Problem Codes	Crack (1135); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential lot numbers: 3293519, 3148018; potential expiration dates: 10/01/2021, 02/03/2021; potential device manufacturer dates: 10/27/2016, 02/05/2016.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 crack and rupture in the tube, located under the flange.The issue was observed by the patient's mother during a standard tube change.The tube was in situ for three weeks before a change took place.The tube had been reused for the fourth time when the event occurred.The tube was cleaned as noted in the device's instructions for use.A new tracheostomy tube was placed to address the issue.No patient injury was reported.
Additional Manufacturer Narrative
One used portex® bivona® uncuffed pediatric tracheostomy tube was received for investigation.A device history record was reviewed for all reported potential lot numbers, and no discrepancies were found.A visual inspection of the device was performed and it was observed that the sample had a split at the bottom of the shaft.A manufacturing review for a similar device was performed, and no discrepancies were found.The most probably root causes were determined to be that the shaft was damaged during the assembly process, or that the product was damaged after it left the manufacturing facility.The complaint was confirmed.

• 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: 6427397
• Report Number: 3012307300-2017-00715
• Device Sequence Number: 18841371
• Product Code: BTO
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: Patient Family Member or Friend
• Device Catalogue Number: 60SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1