MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 70XLTCP

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after twelve days of patient use, a tracheostomy tube cuff was leaking.The tube was then exchanged for a new device, without patient harm.

Manufacturer Narrative

Covidien reference: (b)(4).The tracheostomy tube was returned for investigation.The reported defect could not be detected on the returned sample.The most probable root cause of this type of defect is an inflation device remained in the inflation valve permitting the cuff to deflate.

Manufacturer Narrative

(b)(4).Additional follow up efforts were performed to collect information related to patient identifier.New information was provided from the customer indicating that patient information was not available.Information has been added to the database.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer (Section G): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5026538
• MDR Text Key: 23903459
• Report Number: 2936999-2015-00688
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70XLTCP
• Device Catalogue Number: 70XLTCP
• Device Lot Number: 201410039X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR