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

Catalog Number 100/506/040

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

Reporter noted an age of (b)(6) years and an age of (b)(6) years for the patient.The correct age is unknown.Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.

Event Description

It was reported that a portex® blue line® uncuffed tracheostomy tube was torn.The patient's father noticed the torn device.The tracheostomy tube had been inserted 2-3 weeks before the event.A tracheostomy tube change was performed.No injury was reported.

Manufacturer Narrative

One portex® blue line® uncuffed tracheostomy tube was received for investigation.A visual inspection revealed the tube was broken near the welded area between the flange and the tube.A manufacturing review of a similar device was performed and no discrepancies were found.A root cause for the fault was unable to be determined.

Event Description

The patient was hospitalized.The event occurred in the reporter's hospital ward.The patient was being treated with sirolimus due to the patient's pulmonary disease.The event was considered resolved.

• Brand Name: PORTEX® BLUE LINE® UNCUFFED 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6694485
• MDR Text Key: 79356258
• Report Number: 3012307300-2017-01430
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Catalogue Number: 100/506/040
• Device Lot Number: 3136085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR
• Patient Weight: 15