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

Catalog Number	60N030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
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.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Event or Problem Description
It was reported that during patient use of the bivona® uncuffed neonatal tracheostomy tube, the shaft detached from the neck flange.The event occurred spontaneously at the patient's home and was observed by the patient's family.After the reported issue was observed, the tracheostomy tube was replaced by one of the patient's family members.The device had previously been "vaporized as described in the device instruction manual".It was reported that no patient injury occurred.
Additional Manufacturer Narrative
One bivona® 3.0 mm uncuffed neonatal tracheostomy tube was returned for investigation.Additionally, photographs were provided for review.Visual examination of the returned device and provided photographs found that blue-colored printing was located on the device neck flange.Based upon the observed blue-colored printing, investigation determined that the device had been manufactured prior to the year 2009.The blue-colored print was discontinued several years prior to the introduction of the tr3 pediatric product.Another indicator is the presence of a swivel connector, while the tr3 devices contain a solid taper connector.The first lot of tr3 for a 60n030 part number expired on (b)(6) 2014.Although the reported issue was observed, it was found that the device had exceeded the products five year shelf life.Investigation determined that the root cause of the observed issue was the use of the device in a manner inconsistent with the device instructions for use.

• Brand Name: BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE
• 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: 6415269
• Report Number: 3012307300-2017-00683
• Device Sequence Number: 16275652
• Product Code: BTO
• UDI-Device Identifier: 15021312005691
• UDI-Public: 15021312005691
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: 60N030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1