MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBES

Catalog Number 8DCT

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A report was received stating a tracheostomy tubes dimensions are out of specifications.It was reported that the decannulation stopper would not fit the tracheostomy tube the patient is using at this time.The patient stated the stopper fits all other tubes.The patient was not re-cannulated.

Manufacturer Narrative

(b)(4).

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBES
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4193445
• MDR Text Key: 20772060
• Report Number: 2936999-2014-00882
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8DCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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