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

Catalog Number	67NFPS30
Medical Device Problem Codes	Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a smiths medical portex® bivona flextend¿ tts¿ tracheostomy tube did not inflate when attempted to be filled with sterile water.The balloon to the tracheostomy bulged with no noted sterile water reaching the cuff and was thought to be occluded.Subsequently, the patient required endotracheal intubation to secure the airway.No further adverse patient's effects were reported.
Additional Manufacturer Narrative
One portex® bivona flextend¿ tts¿ tracheostomy tube was received for analysis in used condition.The customer's reported problem was "trach cuff did not inflate when filled with sterile water".The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.No damage could be detected on the unit.The unit was inflated with air.The pilot balloon inflated, but the air was stuck in the pilot balloon.The pilot balloon was squeezed and a small amount of air entered into the cuff.The pilot balloon was squeezed and the cuff was manipulated until the cuff was inflated.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.Inflation test was audited on (b)(4) samples on the production line to verify that the inflation test was properly performed.All (b)(4) units inflated uniformly.There is no root cause for this event since the complaint was not confirmed.

• Brand Name: PORTEX® BIVONA 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: 6952375
• Report Number: 3012307300-2017-02190
• Device Sequence Number: 10948881
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: 10351688518781
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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: Respiratory Therapist
• Device Expiration Date: 12/17/2021
• Device Catalogue Number: 67NFPS30
• Device Lot Number: 3324884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention