MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 80XLTCP

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The covidien technical support engineer spoke with the patient's respiratory therapist (rt) over the phone.The rt stated that the cut occurred when the inner cannula was forced into the tracheostomy, when the patient was in a compressed position.There is no problem inserting the inner cannula when the patient is lying on their back.The product is not being returned for investigation.The lot number was not provided, therefor the device manufacture date is unknown.

Event Description

It was reported that during patient use, the inner cannula of a tracheostomy tube was found to be cut.This was identified after the inner cannula was removed from the patient.The tracheostomy tube was not replaced as they continued to use the inner cannula.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).Additional follow up efforts were performed to collect information related to patient identifier.To date, multiple attempts were made however; no additional information was provided and/or no response has been received.Information has been added to the database.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer (Section G): COVIDIEN; cornamaddy; athlone ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4926592
• MDR Text Key: 22508684
• Report Number: 2936999-2015-00631
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Followup
• Report Date: 06/30/2015

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: Health Professional
• Device Model Number: 80XLTCP
• Device Catalogue Number: 80XLTCP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR