MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSOMY TUBE

Model Number 8CFN

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported that one day after intubation,the inner cannula of the tracheostomy tube was allegedly stuck in the outer cannula because of problems with the snaplock.The patient was reintubated without any reported harm or injury and the patient's current condition is reported to be "good." it is unknown whether the traacheostomy tube had been treated with any disinfection or cleaning solutions.There is no report of death or serious injury associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The tracheostomy tube was returned for investigation.A visual inspection was performed and found all the components were assembled properly.A functional test was performed and the inner cannula was inserted into the outer cannula.The lock was closed with no difficulty.Then the lock was opened and the cannula removed without difficulty.The locks on the connector were measured and found to be within specification.The reported malfunction could not be duplicated with the returned sample.The manufacturing controls and guidelines were reviewed and found acceptable to identify the reported malfunction.

• Brand Name: SHILEY
• Type of Device: TRACHEOSOMY 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: 4720107
• MDR Text Key: 15310836
• Report Number: 2936999-2015-00288
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8CFN
• Device Catalogue Number: 8CFN
• Device Lot Number: 14A0572JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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