MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL TRACHEOSTOMY TUBESTRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO

Catalog Number	60P045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical bivona uncuffed neonatal tracheostomy tube had split completely apart, with the entire distal cannula shaft disappearing and entering into the patient's left main stem bronchus.911 was called.The child was brought to children's hospital of (b)(6).There was no respiratory distress noted.The remaining cannula shaft was removed from her airway and a new, sterile 4.5 pediatric cuffless standard was inserted into her stoma.The child is breathing on her own.No additional adverse patient effects.

• Brand Name: BIVONA UNCUFFED NEONATAL TRACHEOSTOMY TUBESTRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8609666
• Report Number: 3012307300-2019-02696
• Device Sequence Number: 2339604
• Product Code: BTO
• UDI-Device Identifier: 15021312005769
• UDI-Public: 15021312005769
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 11/06/2023
• Device Catalogue Number: 60P045
• Device Lot Number: 3723194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/14/2019
• 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
• Patient Age: 10 YR