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

Catalog Number	FT14GN40NGF201N
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that four days following placement of a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube the balloon was found to be empty with no visible leak upon check.It was noted that the father checked prior to use with no leak.The device was returned for evaluation following trach change out.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.The returned device was leak tested with air.The device cuff inflated but immediately began deflating as air escaped from the airway line on the side of the shaft next to the neck flange.This confirms the reported complaint.Under magnification it was noticed that the airway line had been torn away from the device shaft, which is where the air was escaping the device causing the cuff to lose air.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• 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: 8024829
• Report Number: 3012307300-2018-01950
• Device Sequence Number: 1407469
• Product Code: JOH
• UDI-Device Identifier: 10351688739407
• UDI-Public: 10351688739407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: Lay User/Patient
• Device Expiration Date: 09/13/2023
• Device Catalogue Number: FT14GN40NGF201N
• Device Lot Number: DS019979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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