MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60SP040
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Erythema (1840); Obstruction/Occlusion (2422)
Date of Event	11/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.
Event or Problem Description
It was reported that while a patient was using a portex® bivona® uncuffed neonatal and pediatric tracheostomy tube, the trach disconnected from the flange in the patient's trachea.The mom retrieved the shaft with a tweezers and placed a new trach.Patient had an abnormal sound to her breathing, but did not exhibit any color change or other symptoms of respiratory distress.The event was resolved.No other adverse events were reported.
Additional Manufacturer Narrative
Photographs were returned for evaluation.Photographic inspection showed that the tracheostomy shaft was disconnected from the flange.One device was returned for evaluation without its original packaging.Visual inspection of the device found the flange broken from the neck strap base.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A sample of (b)(4) devices was taken from the production floor for tensile testing to failure and found that the devices all broke at the tube end and not from the bonding between the tube and neck strap.Based on the evidence, the root cause was attributed to a manufacturing issue; the most probable cause related to the adhesive not being properly applied.
Event or Problem Description
The patient's physician described the stoma to be "mildly erythematous".The patient's mother removed the defective shaft and replaced with a new tracheostomy tube.The event was considered resolved.
Event or Problem Description
The tracheostomy tube was inserted the night before the date of the event.The tube was secured with dale tracheostomy tube ties.It was observed that there were secretions on the inside and outside of the tube.There was difficulty removing the tube.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC 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: 7072410
• Report Number: 3012307300-2017-02507
• Device Sequence Number: 945046
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2018

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?: No
• Operator of Device: Patient Family Member or Friend
• Device Catalogue Number: 60SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/30/2017; 12/21/2017; 03/01/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/06/2017; 01/04/2018; 03/19/2018
• 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: 5 YR
• Patient Weight: 41