MAUDE Adverse Event Report: TRACOE CUSTOM TRACHEOSTOMY TUBE; CUSTOM TRACH TUBE

Model Number TRACOE TRACH

Device Problems Bent (1059); Structural Problem (2506); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)

Patient Problem Extubate (2402)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Pt received at least 2 custom tracheostomy tubes that are not the same as her previous trachs.The defects include the following: the angle of the cannula is incorrect, the correct cannula angles straight down right after the hub; the defective tracheostomy tubes have a longer horizontal section before it angles down.The cannula is shifted off to one side.The hub is not round, it appears to be warped.(b)(6) checked inventory and we had one tracheostomy tube for pt on our shelf.Upon inspection, this tracheostomy tube is also manufactured incorrectly (same complaints as above.We received another tube today for pt, and the one received today is correct and is a separate lot number, and will be shipped out to the pt.Pt's nurse took picture of the defects - these will be sent with the defective tracheostomy tube back to the mfr.Pt requires a tracheostomy tube for trachea stoma at all times.Pt requires being mechanically ventilated with oxygen in-line on an ltv950 ventilator with a mr730 heater for support while sleeping and prn when ill.Pt's heart rate and oxygen saturations are monitorized by a n600x oximeter, and has a portable and stationary suction machine in the home available at all times to clear secretions from trachea.

• Brand Name: CUSTOM TRACHEOSTOMY TUBE
• Type of Device: CUSTOM TRACH TUBE
• Manufacturer (Section D): TRACOE; nieder-olm rhineland-palatinat DE 5 5268
• MDR Report Key: 3612591
• MDR Text Key: 18301289
• Report Number: MW5034204
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRACOE TRACH
• Device Lot Number: 21487
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR