MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BOCALAID TRACHEOSTOMY TUBE

Catalog Number 100/517/075J

Device Problems Leak/Splash (1354); Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

A report was received indicating that the listed tracheostomy tube was checked for leaks prior to intubation, and no leaks were observed.However, after an unreported about of time, a leak became apparent.The reporter indicated that the pilot balloon was torn as it came into contact with the device operator while the operator was changing the patient's gauze.The reporter indicated that no patient injury occurred from the event.

Manufacturer Narrative

The reported bl vocalaid trach 7.5mm (b)(6) version was returned for investigation.The returned device was sample was received inside a plastic bag and without its original package.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination.The visual inspection confirmed that the inflation line was torn or cut with a sharp object.No root cause was determined but the complaint was confirmed.

• Brand Name: PORTEX BOCALAID TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5463109
• MDR Text Key: 39484075
• Report Number: 2183502-2016-00301
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: OUS ONLY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/517/075J
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• 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: N
• Patient Sequence Number: 1