MAUDE Adverse Event Report: COVIDIEN SHILEY; UNSPECIFIED TRACHEAL TUBE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Extubate (2402)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.The customer did not retain the model and lot number which determines the date of manufacture and the 510k.

Event Description

A trached patient was sent to health service center for 2 days.When the patient came back the tracheostomy tube size could not be identified as size labeling wore off.The tracheostomy tube was approximately 2 weeks old.The tube was removed and replaced.There was no patient harm.The device will not be returned for evaluation.

• Brand Name: SHILEY
• Type of Device: UNSPECIFIED TRACHEAL TUBE
• Manufacturer (Section D): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer (Section G): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6078059
• MDR Text Key: 59118891
• Report Number: 2936999-2016-00920
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• 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
• Patient Outcome(s): Required Intervention