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

Catalog Number	67PFP60
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 the cuff of a portex® bivona flextend¿ tts¿ pediatric tracheostomy tube was asymmetrical, causing a leak when used with a patient's ventilator; making it difficult to ventilate the patient.No injury was reported.
Additional Manufacturer Narrative
Two devices were returned for evaluation without their original packaging.Visual inspection found no damage on the devices.Leak testing was performed and did not observe any leakage.Air cuff symmetry testing was performed and found that the devices did not inflate uniformly.The devices underwent inflation instructions per the instructions for use and met specifications.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 review of 32 assemblies was performed for inflation and leak testing and did not observe any issues.Based on the evidence, a root cause was unable to be determined.The device performed within manufacturing specifications.

• Brand Name: PORTEX® BIVONA FLEXTEND¿ TTS¿ 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: 6563670
• Report Number: 3012307300-2017-01020
• Device Sequence Number: 11021104
• Product Code: JOH
• UDI-Device Identifier: 10351688518538
• UDI-Public: 10351688518538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: 67PFP60
• Device Lot Number: 3216439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1