MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number UNKTRACH

Device Problem Sticking (1597)

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

Event Type  malfunction  

Event Description

It was reported that the product becomes "stuck to the ventilator due to the increased humidification the tracheostomy tube offers".There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Covidien reference: (b)(4).It was reported that while in use, a tracheostomy tube became "stuck" to a ventilator.The investigation has determined that the disconnection forces may be excessive for the care giver to disconnect an accessory from the products 15mm connector.The fundamental design of the 15mm connector is to have an air tight fit between it and the female connector device, so that it will not disconnect during patient use.Improvements to the connector are being implemented.The product involved in this complaint is part of a field safety corrective action (fsca) unrelated to the 15 mm connector issue.The product is no longer on the market.The product is currently being redesigned.All manufacturing lines will be revalidated before the product is re-released to the market.

• 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: 4691168
• MDR Text Key: 5672354
• Report Number: 2936999-2015-00330
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKTRACH
• Device Catalogue Number: UNKTRACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• 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: Unknown
• Patient Sequence Number: 1