MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 6FEN

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the cuff leak detection procedure was performed prior to use, air leakage was observed from the cuff.There is no report of patient involvement.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).During inflation testing cuff deflation was confirmed on the returned fenestrated tracheostomy tube.Visual inspection confirmed there was a cut to the inflation line and a leak was confirmed.The manufacturing guidelines and controls were reviewed and found effective to detect this type of failure mode.The reported malfunction is not related to the manufacturing process.

• 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: 4960023
• MDR Text Key: 23419152
• Report Number: 2936999-2015-00667
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6FEN
• Device Catalogue Number: 6FEN
• Device Lot Number: 13K0614JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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