MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/810/060

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that the size of this tracheostomy tube contributed to obstruction of the airway due to increased secretions and airway resistance.As a result, undefined adverse events were encountered and required a tracheostomy tube change out.No additional adverse patient effects were reported.

• Brand Name: PORTEX® PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; a d no.4; parque industrial internaciona; tijuana, bc ; MX
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7138773
• MDR Text Key: 95511864
• Report Number: 3012307300-2017-02610
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: 100/810/060
• Device Lot Number: 3159839
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention