MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 6FEN

Device Problem Unintended Movement (3026)

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

Event Date 03/03/2015

Event Type  Injury  

Event Description

It was reported that a few days post- tracheostomy, the patient noticed that the inner cannula was not in a fixed position and was often moving.The same general surgeon then replaced the involved tracheostomy tube with another of the same type without any reported patient harm.There is no report of death or serious injury associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Covidien/medtronic reference number (b)(4).No customer sample was available for analysis.A review of the complaint database found there are no additional complaints with the same lot number and the same failure mode.A review of the lot history record for the reported device found it met all quality requirements and specifications prior to it's release.The reported issue could not be confirmed and the cause cannot be determined, however, manufacturing controls are in place to detect the reported complaint during the manufacturing process.Complaint trends will continue to be monitored.Ifu warnings include: all inner cannulae with twist-lock connectors provided in this package should not be used on any other tubes because they are fitted to the exact length of this tube.During and afer attachment of respiratory or anesthesia tubing and/or connectors to the inner cannula, avoid application of excessive rotational, linear, or rocking forces on the tubing and/or connectors to prevent accidental disconnection of the inner cannula, or damage to the tracheostomy tube.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• 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: 4727914
• MDR Text Key: 5745177
• Report Number: 2936999-2015-00280
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K962173
• 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,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6FEN
• Device Catalogue Number: 6FEN
• Device Lot Number: 1007001582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2015
• 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 Outcome(s): Required Intervention