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

Model Number	FT19KN55NGF941N
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona flextend¿ tts¿ neonatal and pediatric tracheostomy tube "blew." the patient was reported to have an audible leak with no etco2 and decreased tidal volumes.Ent was called to assist since the patient had a history of being a difficult airway.Subsequently, the trach tube was changed out.The following night, a leak was reported to have developed with the replacement trach.The patient is stable but is ventilator dependent and is awaiting replacement trach tube.The tubes were later returned for analysis.
Additional Manufacturer Narrative
Four samples were returned for analysis.Three of the four were observed to have leakages.Two of the cuffs were noted to have abrasions to the general area of the leak.A small hole was found to one in the abrasion area and the other had it in the opposite area.Based on the evidence the complaint was confirmed.However, the root cause is unknown.It is stated that by they area of abrasions and the holes, it is thought that the cause is from the patient's anatomy.

• Brand Name: PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9506356
• Report Number: 3012307300-2019-07471
• Device Sequence Number: 11282531
• Product Code: JOH
• UDI-Device Identifier: 15019517211825
• UDI-Public: 15019517211825
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• Device Model Number: FT19KN55NGF941N
• Device Catalogue Number: FT19KN55NGF941N
• Device Lot Number: SS025220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 8 YR
• Patient Weight: 27