MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT17FN35NGE915N
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex bivona custom flextend tracheostomy tube was placed into a patient and determined to be "defective" two days later.It was reported the "valve in the balloon line was floating back and forth in the line".Subsequently, a tracheostomy (trach) change out was required.There were no adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: one bivona trach tube was returned for inspection.  the returned-product had the airway tubing entirely severed; the teflon tubing was dislocated from its required position and was found midway up the airway tubing toward the pilot balloon. additionally, the customer sent a photo that showit was reported the device with a non-severed airway tubing, but with the teflon tubing also out of place.   the returned device was compared to the routine inspection criteria, and there were no issues noted that would have made the device more susceptible to dislocation of teflon tubing. all devices are submit to 100% inspection, so it is unlikely that the device was sent out with the teflon out of position.  it is possible that excessive manipulation of the product (specifically the airway tubing) by the end user led to the teflon tubing becoming displaced; the fact that the returned sample was completely severed lends backing to this theory.This complaint was communicated to manufacturing personnel to raise awareness for this potential issue.  based on the fact that the exact root cause of why the teflon tubing became displaced cannot be determined, there are no further actions planned at this time.  smiths-medical regularly monitors complaints for trends, and may take additional actions regarding this issue if deemed appropriate.

• Brand Name: PORTEX BIVONA CUSTOM FLEXTEND 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: 8547171
• Report Number: 3012307300-2019-02230
• Device Sequence Number: 1744716
• Product Code: JOH
• UDI-Device Identifier: 15019517110197
• UDI-Public: 15019517110197
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: FT17FN35NGE915N
• Device Catalogue Number: FT17FN35NGE915N
• Device Lot Number: SS020661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR