MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA CUSTOM 8.0 FLEXTEND TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT18KN80NSC884N
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the rigid plastic connector came off of a smiths medical portex bivona custom 8.0 flextend tts tracheostomy tube while disconnecting the patient's ventilator from their tracheostomy (trach) tube.Subsequently, a trach change out was required.No clinical consequences to the patient were reported.The event was noted as resolved.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Upon visual inspection, it was noted the swivel component was completely separated from the rest of the device.This subcomponent is intended to be kept in place by a retaining ring which is secured with adhesive.When manipulating the assembled device, the area with the retaining ring did not have the rigidity expected by the retaining ring.This allowed the swivel part to be slid off its intended location with greater ease than is expected.It appeared that the adhesive securing the retaining ring was still intact, however the retaining ring appeared to be damaged.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX BIVONA CUSTOM 8.0 FLEXTEND 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: 8244140
• Report Number: 3012307300-2019-00228
• Device Sequence Number: 2203298
• Product Code: JOH
• UDI-Device Identifier: 15019517173659
• UDI-Public: 15019517173659
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: No Information
• Device Expiration Date: 12/07/2023
• Device Model Number: FT18KN80NSC884N
• Device Catalogue Number: FT18KN80NSC884N
• Device Lot Number: SS018652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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: 23 YR