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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	Respiratory Acidosis (2482)
Date of Event	11/24/2019
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 decreased tidal volumes, vitals decompensated high co2, and an audible leak was noted the trach tube was immediately changed out.Ent was called to the bedside of the patient to assist with the placement.Subsequently, at approximately 3am, the replacement tube also leaked.The patient is reported to be stable but is awaiting a new back-up trach tube.The product was returned for analysis.
Additional Manufacturer Narrative
Evaluation results: four custom bivona tracheostomy tube were returned for investigation.Of the 4 samples received, 3 of them were confirmed to have leakage issues.The two cuffs (manufactured at the tijuana facility) had what appeared to be abrasions in the same general area.One of these parts had a small hole on the perimeter of the abrasion area, while the other had a small hole on the opposite side of the tube.Of the southington-produced parts, one was confirmed to have a small hole in the same general area of the aforementioned abrasions.The other southington-produced part was tested and no leakage issues were noted.Based on the fact that the 3 tubes exhibiting leakage issues all had abrasions and/or holes in the same general area of the cuff when they were examined by looking at the tube from above with the curve in a "concave down" formation, the holes/abrasions near the center of the upper portion of the cuff appeared slightly closer to the airway side of the cuff.This combined with the fact that these products were built at two different facilities, gave rise to the hypothesis that the abrasions/holes were possibly caused by unique features of the patient's anatomy.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.

• 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: 9506170
• Report Number: 3012307300-2019-07444
• Device Sequence Number: 16529500
• 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): 02/28/2020

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: 12/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/28/2020
• 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