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

Model Number ST17FN70NSB128N

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Possible lot number are: bs001477, bs002617, bs002618.

Event Description

Information was received that a smiths medical customized portex bivona tracheostomy tube, had issues, not sitting properly.No adverse patient effects were reported.

• Brand Name: CUSTOMIZED PORTEX BIVONA TRACHEOSTOMY TUBE
• Type of Device: TUBTUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary, in
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9863270
• MDR Text Key: 184422675
• Report Number: 3012307300-2020-02116
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517111699
• UDI-Public: 15019517111699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ST17FN70NSB128N
• Device Catalogue Number: ST17FN70NSB128N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1