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

Catalog Number 100/870/070

Device Problems Air Leak (1008); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A user facility reported that a pressure gauge was in use with the listed tracheostomy tube, when a leak was detected in the tracheostomy tube's cuff.The tracheostomy tube was in use with the patient for an unknown amount of time when the cuff was found leaking.The tracheostomy tube was replaced.The removed tracheostomy tube was investigated and was allegedly observed having an occluded inflation line.No incident related medical sequela was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the suspect tracheostomy tube was returned for investigation.Visual inspection found the device free of defects and abnormalities.Submersion of the inflated device detected no bubbles or leaks.Review of the device history record revealed no non-conformities during manufacturing.The reported product issue could not be reproduced.As no fault was observed with the returned device, no evidence has been found to suggest the reported event was related to an intrinsic product problem.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT
• Type of Device: BTO - TRACHEOSTOMY TUBE
• 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: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4812367
• MDR Text Key: 5924438
• Report Number: 2183502-2015-00376
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 100/870/070
• Device Lot Number: 2384064
• 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: 05/26/2015
• Device Age: 2 YR
• Event Location: Home
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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