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

Catalog Number	60P040
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: k912469 and k083641.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a portex® bivona® uncuffed neonatal and pediatric tracheostomy tube left eyelet tore three-quarters of the way during use on a patient.The issue was observed by the patient's parent when she awoke from a nap.The tracheostomy tube had been in use for 2 weeks.It was noted that dale tracheostomy tube ties had been used to hold the tube in place.The tube was discarded and replaced with a new tracheostomy tube.No patient injury was reported.The issue was considered resolved.

• 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: 6522742
• Report Number: 3012307300-2017-00893
• Device Sequence Number: 18835822
• Product Code: BTO
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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: 60P040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 MO
• Patient Weight: 14