MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT; BTO - TRACHEOSTOMY TUBE KIT

Catalog Number 100/870/080

Device Problems Air Leak (1008); Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

A report was received stating that the tracheostomy tube was deflating at the cuff after an unknown amount of time in situ.The tracheostomy tube was replaced.The user reported that the cuff was found ruptured on the removed device.No adverse effects to patient reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for evaluation.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 evaluation.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT
• Type of Device: BTO - TRACHEOSTOMY TUBE KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry rd.; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4032067
• MDR Text Key: 4842248
• Report Number: 2183502-2014-00558
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 100/870/080
• Device Lot Number: 2491832
• 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: 08/04/2014
• Distributor Facility Aware Date: 07/14/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2004
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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