MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TRACHEOSTOMY TUBE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Report received stating that patient received a tracheostomy tube on (b)(6) 2015.On (b)(6) 2016, the 15 mm connector piece became loose from the tracheostomy tube and was unable to be reattached.This failure resulted in the need of a tracheostomy tube change.Patient was recannulated with another similar device without issue.No adverse health outcome resulted from this event.

Manufacturer Narrative

The reported uniperc adjustable flange tracheostomy tube cuffed, 8mm device was returned for investigation.Under visual inspection the failure was confirmed - 15mm white connector was disconnected from the tube.There were no other defects or damages observed.Therefore complaint is confirmed as a manufacturing issue.(b)(4).

• Brand Name: PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5410620
• MDR Text Key: 37488620
• Report Number: 2183502-2016-00137
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• 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
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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