MAUDE Adverse Event Report: COVIDIEN SHILEY; DISP.CAN.P-C 6-10.0 BX1

Model Number 6DCT

Device Problem Air Leak (1008)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the tracheostomy tube was tested prior to use.During patient use the cuff would not hold air after a few hours.Condensation in the pilot balloon and air escaping around the pilot balloon was noted.The tube was removed and replaced.This happened 3 times with this patient.The 3 tubes for this incident are referenced on our reports 2936999-2016-00311, 2936999-2016-00313, 2936999-2016-00314.

Manufacturer Narrative

(b)(4).The reported failure of the cuff wont inflate was verified due to a tear /cut in the tracheal tube cuff.The manufacturing guidelines and controls were reviewed and found effective to detect this type of failure mode.The reported malfunction is not related to the manufacturing process.

• Brand Name: SHILEY
• Type of Device: DISP.CAN.P-C 6-10.0 BX1
• 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: 5608200
• MDR Text Key: 43647121
• Report Number: 2936999-2016-00314
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Device Lot Number: 15K0654JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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