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

Catalog Number	67PFPS50
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
User facility reported that a tracheostomy tube cuff leaked after the tube had been in situ for 7 days.The cannula had been previously cleaned with tracoe cleaning powder.No patient or clinical injury were associated with this incident.After the tracheostomy tube was removed, the cuff leak was visually confirmed by filling the cuff inflation line with water and observing the leak.
Additional Manufacturer Narrative
Two smiths medical portex bivona flextend¿ tts¿ tracheostomy tubes were returned for analysis within the same bag.Three (3) pictures were also received for inspection; in picture 1 and picture 2 we can see the units in used conditions and in picture 3, we can see a leak in cuff.A hole on the cuff of both samples were noted under visual examination.Both samples were leak tested under water; revealing leaks to the cuffs of both samples and confirming the complaint.Relevant documents were reviewed and considered adequate for testing.A review of the manufacturing process indicating that all procedures are being carried out appropriate.The assembly process was reviewed according to the procedures listed above.The training was reviewed and it was confirmed that the personnel had the trainings up to date.Thirty-two assemblies were reviewed to see the complete manufacturing process of the air way and balloon and leak tested at 100%.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is due to damage that occurred after the product left the shm facility.

• Brand Name: PORTEX® BIVONA® FLEXTEND¿ TTS¿ PEDIATRIC STRAIGHT NECK FLANGE 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: 7520318
• Report Number: 3012307300-2018-01574
• Device Sequence Number: 13877140
• Product Code: JOH
• UDI-Device Identifier: 10351688518569
• UDI-Public: 10351688518569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: Health Professional
• Device Expiration Date: 05/20/2022
• Device Catalogue Number: 67PFPS50
• Device Lot Number: 3428816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1