MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBES

Model Number 5.0 PED

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that the flange of the tracheostomy tube broke and the tracheostomy tube came out.Although requested, no additional information has been provided.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The customer reported failure mode of a crack in the flange was confirmed in the returned sample.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.Complaint trends will continue to be monitored.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBES
• 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: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4473968
• MDR Text Key: 5564580
• Report Number: 2936999-2015-00026
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.0 PED
• Device Catalogue Number: 5.0 PED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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