MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 536080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/17/2018

Event Type  malfunction  

Event Description

Patient undergoing planned trach placement.The cuff was tested by the doctor prior to insertion but once inserted, the balloon on the cuff would not hold air.Dr replaced the trach with a second trach of the same size, make and lot number.The second trach cuff was also tested before insertion and seemed to be in working order; once inserted, it would not maintain air in the cuff.The trach was then replaced again and this third trach worked as we would expect.This issue did cause delay in patient care due to the insertion and removal of 2 trachs prior to the final placement.Manufacturer response for trach tube, (brand not provided) (per site reporter): i spoke to customer services and they are contacting quality control and they will be in-touch with me within 48 hours.I have two to send back.

• Brand Name: PORTEX
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7288772
• MDR Text Key: 100687916
• Report Number: 7288772
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/25/2022
• Device Model Number: 536080
• Device Catalogue Number: 536080
• Device Lot Number: 3503950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: I DON'T BELIEVE SO