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

Catalog Number	XT15GS40NGF181N
Medical Device Problem Codes	Split (2537); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that a portex® bivona® custom flextend¿ tts¿ neonatal and pediatric tracheostomy tube split into two after a few hours of use.The issue was observed by the patient's mother early in the day during attempt to suction the patient.It was noted that the patient's mother encountered resistance in the tube.The tube cuff was filled with air.The tracheostomy tube was changed immediately.No patient injury was reported.
Additional Manufacturer Narrative
One bivona® 4.0mm customized flextend¿ hyperflex¿ tracheostomy tube was returned for investigation.Visual inspection revealed that the returned device was broken.The break was located on the distal side of the shaft, below the neck flange.Examination found that the tracheostomy tube shaft had split horizontally and in line with the internal wire.Investigation was unable to determine the root cause of the observed shaft break.

• Brand Name: PORTEX® BIVONA® CUSTOM FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• 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: 6439286
• Report Number: 3012307300-2017-00764
• Device Sequence Number: 18974070
• Product Code: JOH
• UDI-Device Identifier: 10351688853783
• UDI-Public: 10351688853783
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 10/11/2021
• Device Catalogue Number: XT15GS40NGF181N
• Device Lot Number: GS031345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided; 04/04/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/22/2017; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 12