MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 6DCFS

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Irritation (1941); Discomfort (2330)

Event Date 10/07/2014

Event Type  Injury  

Event Description

Covidien received a report from a durable medical equipment (dme) supplier that one of their home patients was experiencing airway irritation,discomfort,coughing and some bleeding after inserting and using a disposable inner cannula(dic) from a new box.The patient had indicated that the dic protruded from the end of her tracheostomy tube and caused her symptoms.The patient then replaced that trach tube with a spare tube she had at home, returned that tracheostomy tube in use at time of report and a sample of dic to the dme office.The dme manager sent the patient home with an alternate new box of disposable inner cannulas.The patient did not require a physician visit for the issue per the dme and has not called back with any added complaints.

Manufacturer Narrative

Requests for information and disposition of devices for return for evaluation have been made by covidien.(b)(4).

Manufacturer Narrative

The reporter stated that the patient is "doing fine", and has had no further complaints about the previously reported 'irritation".Reporter had originally indicated that the device would be returned for evaluation, and now states that the device will not be returned at this time.(b)(4).

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO ; 3038768909
• MDR Report Key: 4228343
• MDR Text Key: 4971175
• Report Number: 2936999-2014-00948
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6DCFS
• Device Catalogue Number: 6DCFS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHILEY TRACHEOSTOMY TUBE
• Patient Outcome(s): Required Intervention