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

Catalog Number	60SP035
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k): 4083641.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 the patient's parents could not remove the heat moisture exchanger (hme) from the hub of a portex® bivona® uncuffed pediatric tracheostomy tube.It was noted that the event resulted in "decannulation".No patient injury was reported.See mfr: 3012307300-2017-01053.
Additional Manufacturer Narrative
One device was returned for evaluation.Functional testing of the device involved a taper gage check and found the components within dimensional specifications and that the insertion of the connector into the hme filter had no issues.It was indicated that the hme adapter would not separate from the connector if too much force was applied.A review of the device master record was performed and found to be complete.The investigation did not reveal any intrinsic manufacturing defects.Based on the evidence, the root cause was attributed to a user error, due to the user interfacing with the product in a manner inconsistent with the instructions for use.

• Brand Name: PORTEX® BIVONA® UNCUFFED PEDIATRIC 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: 6573158
• Report Number: 3012307300-2017-01052
• Device Sequence Number: 13455899
• Product Code: BTO
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 60SP035
• Device Lot Number: 3166696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1