MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 18770

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Date 01/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned tracheal tube was evaluated for the reported "cuff won't inflate" event.The cuff was confirmed to have a leak.All manufacturing controls were found acceptable and effective to detect the reported failure mode.An inflation test is performed for all taperguard products.The operator inspects all products for no leaks and segregates the defective parts.All taperguard products have a resting time of 2 hours.A deflation test is performed for all taperguard products.The operator inspects for no leaks and segregates the defective parts.

Event Description

A report was received stating, several minutes after intubation the tracheostomy tube experienced an air leak.Recannulation of the patient was required.There was no patient harm reported.The cuff was reported to have passed "prior to use" testing.There was 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: 4485744
• MDR Text Key: 14249461
• Report Number: 2936999-2015-00113
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 14H450JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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