MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; BTO TRACHEOSTOMY TUBES

Catalog Number 100/523/070

Device Problem Locking mechanism failure (2593)

Patient Problem Therapy/non-surgical treatment, additional (2519)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

User facility reported after a few days in use the locking mechanism did not hold the tracheostomy tube and flange in place.A tracheostomy tube change was performed.No adverse effects to pt were reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device eval.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the eval.

• Brand Name: PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: BTO TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundry rd; hythe, kent CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3829673
• MDR Text Key: 21722317
• Report Number: 2183502-2014-00268
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 100/523/070
• Device Lot Number: 1838380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2014
• Distributor Facility Aware Date: 04/03/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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