MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CUSTOMIZED PORTEX BIVONA TRACHEOSTOMY TUBE; TUBTUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO

Model Number	ST17FN70NSB128N
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Possible lot number are: bs001477, bs002617, bs002618.
Event or Problem Description
Information was received that a smiths medical customized portex bivona tracheostomy tube, had issues, pinching the patient.No further adverse patient effects were reported.

• Brand Name: CUSTOMIZED PORTEX BIVONA TRACHEOSTOMY TUBE
• Common Device Name: TUBTUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9863269
• Report Number: 3012307300-2020-02118
• Device Sequence Number: 3940182
• Product Code: BTO
• UDI-Device Identifier: 15019517111699
• UDI-Public: 15019517111699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ST17FN70NSB128N
• Device Catalogue Number: ST17FN70NSB128N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1