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

Catalog Number	FT16LN45NGF077N
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Hypoxia (1918); Tachycardia (2095); Increased Respiratory Rate (2486)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a patient with a smiths medical portex bivona flextend tts tracheostomy tube was reported to have increased secretions, elevated heart rate, elevated respiratory rate, o2 level decrease, and to be noisy.Subsequently, a tracheostomy (trach) tube change out was required and the patient recovered.It was reported that the patient recovered as "the perfect trach was placed." there were no further reported adverse patient effects.
Additional Manufacturer Narrative
Three bivona flextend tts cuffs tracheostomy tubes were returned for analysis.No defects were identified upon visual examination by naked eye under plant lighting.The length of the three shafts were measured against template specification.The shaft id and od were measured on all three shafts and determined to be correct.A syringe was used to inflate the cuffs for symmetry; all three met manufacturing specifications.Shaft angles were inspected; noting to be within specification.Based on the evidence, the root cause is unknown as the complaint was not confirmed.However, it is suspected that the end user may not be able to tolerate the variation in the manufacturing specification for the shaft angle.

• Brand Name: PORTEX BIVONA FLEXTEND TTS 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: 8027840
• Report Number: 3012307300-2018-01274
• Device Sequence Number: 203082
• Product Code: JOH
• UDI-Device Identifier: 15019517088564
• UDI-Public: 15019517088564
• Combination Product (Y/N): N
• 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): 12/12/2018

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: No Information
• Device Expiration Date: 08/29/2023
• Device Catalogue Number: FT16LN45NGF077N
• Device Lot Number: DS019602
• 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: 11/14/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 20