MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 5.5PCF

Device Problems Air Leak (1008); Inflation Problem (1310)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported that a customer noticed a visual difference in the tracheostomy tube she used for her son.The blue outer cuff had a different shape as previous tracheostomy tubes used - it was flatter.Also it was reported that they had to re-inflate the internal cuff more often and noticed some air leakage and her son produced an unusual noise.The device was not changed (replaced) right away but was advised to change to a different device next time.There was no report of patient harm reported and there is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

• 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: 4796892
• MDR Text Key: 5820145
• Report Number: 2936999-2015-00470
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 05/04/2015

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: Lay User/Patient
• Device Model Number: 5.5PCF
• Device Catalogue Number: 5.5PCF
• Device Lot Number: 13E0691JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• 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