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

Catalog Number	ST16LN35NGG954N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This single-use device is indicated to be reused on a single patient.
Event or Problem Description
Information was received indicating that, when changing the ties on this tracheostomy tube, it was noted that the flange was broken.This was the patient's second time wearing this custom tracheostomy tube.The tracheostomy tube was changed out for a new one.No additional adverse patient effects were reported.

• Brand Name: PORTEX® BIVONA TRACHEOSTOMY TUBE CUSTOMIZATION SERVICES
• 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: 7137588
• Report Number: 3012307300-2017-02552
• Device Sequence Number: 16416876
• Product Code: JOH
• UDI-Device Identifier: 15019517087857
• UDI-Public: 15019517087857
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: Lay User/Patient
• Device Expiration Date: 07/10/2022
• Device Catalogue Number: ST16LN35NGG954N
• Device Lot Number: SS009138
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Weight: 6