MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 5.0PDC

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that, prior to patient use, the tracheostomy tube cuff was leaking air.There was no reported patient involvement.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Covidien reference: (b)(4).One sample of a pediatric tracheostomy tube was received for evaluation.Inflation/deflation tests were performed by applying air to the cuff and observed that the cuff deflated.Performance testing was performed by submerging the device into a container filled with water and detected that air was leaking through the wall of the lumen.The customer reported malfunction was confirmed.All manufacturing controls were reviewed and found effective to detect the reported failure mode.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4552356
• MDR Text Key: 5474574
• Report Number: 2936999-2015-00176
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2015

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: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Device Lot Number: 14H0441JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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