MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 3.5 NEO

Device Problems Material Too Rigid or Stiff (1544); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

A report received from (b)(6) stated that on initial inspection a tracheostomy tube introducer was found to be very stiff.The customer stated they were unhappy with the fit and therefore did not use the device on a pt.

Manufacturer Narrative

Covidien has requested that the sample be returned so an eval can be completed.(b)(4).

Manufacturer Narrative

The device was received and investigated.The obturator and the cannula were inserted and removed without resistance and both were measured and found to be within specification.The reported issue was unable to be duplicated.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4002503
• MDR Text Key: 4955493
• Report Number: 2936999-2014-00583
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3.5 NEO
• Device Catalogue Number: 3.5NEO
• Device Lot Number: 1310692KZX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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