MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFP30
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the flextend portion of the tracheostomy tube was found to be kinked.The fault was noticed when there was increased resistance during suctioning.Once the tube was removed, a "clear pinch" was noticed.The tracheostomy tube was replaced.No permanent injury was reported.
Additional Manufacturer Narrative
One used portex® bivona® tts¿ tracheostomy tube was received with its obturator inside a ziploc bag.Visual inspection was performed at 12" under normal conditions of illumination in order to detect any damage on the part.During the inspection, it was seen that the shaft was damaged and the wire was kinked.A kink test was subsequently performed.The unit failed the kink test.

• Brand Name: PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7546707
• Report Number: 3012307300-2018-01686
• Device Sequence Number: 178682
• Product Code: JOH
• UDI-Device Identifier: 15021312014723
• UDI-Public: 15021312014723
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Catalogue Number: 60NFP30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR