MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 6DCT

Device Problems Air Leak (1008); Leak/Splash (1354)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the cuff on a tracheostomy tube leaked in less than 48 hours.The leak was found when the patient's ventilator tidal volume was affected.An air leak could also be heard.The patient was recannulated and is tolerating well with no incident.

• 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; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5115784
• MDR Text Key: 27201580
• Report Number: 2936999-2015-00844
• 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: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR