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

Catalog Number 100/800/080

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Skin Inflammation (2443); No Code Available (3191)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Foreign : (b)(6).(b)(4).

Event Description

Information was received that a smiths medical portex blue line cuffed tracheostomy tube aperture was inflamed after switching the patient to a new tube.The switch was also reported to "significantly increase the amount of bodily secretions discharged." no additional adverse patient effects were reported.

• Brand Name: PORTEX BLUE LINE CUFFED TRACHEOSTOMY TUBE
• 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 MEDICAL INTERNATIONAL LTD.; boundary road, hythe; kent ct21 6jl; kent, ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8115195
• MDR Text Key: 128746823
• Report Number: 3012307300-2018-08449
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/800/080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1