MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE UNCUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY

Catalog Number 100/506/050

Device Problem Component(s), broken (1103)

Patient Problems Bradycardia (1751); Therapy/non-surgical treatment, additional (2519); Hospitalization required (2580)

Event Type  Injury  

Event Description

Distributor reported on behalf of use facility that the device was in use with a home-care patient when they were hospitalized for bradycardia.After arriving at the hospital, a clinician was inspecting the tracheostomy tube when they found that it had collapsed.An emergent tracheostomy tube change was performed.Following the procedure, the patient's condition improved and they were discharged on (b)(6) 2014.No permanent adverse effects to the patient were reported.

Manufacturer Narrative

Manufacturer completed the entire form.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.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.The actual device involved was returned and is currently in transit to the investigation site.

• Brand Name: PORTEX BLUE LINE UNCUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3733026
• MDR Text Key: 4325069
• Report Number: 2183502-2014-00166
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 100/506/050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2014
• Event Location: Home
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 7 YR