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

Model Number 100/800/075CZ

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2021

Event Type  malfunction  

Event Description

It was reported that the patient was admitted to the intensive care unit due to illness and had difficulty breathing during the process of blocking the tube with a metal sleeve.The tracheotomy catheter was replaced and connected to the ventilator for ventilator assisted breathing and the ventilator reported low airway pressure.It was found that the external air bag had collapsed and the monitored air bag pressure was 0.The attending doctor replaced the tracheotomy intubation and accessories and everything was normal.No patient injury was reported.

Manufacturer Narrative

Other, other text: device evaluation: the investigation of the complaint was limited because no sample was returned.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Each cuff shall be also tested by customer prior use as per instruction for use lls10001031-001 rev.100, page 3, instruction for use section, point 1: "the integrity of the cuff and inflation system should be checked prior to insertion".It is the most probable that reported failure occurred during use or during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use lls10001031-001 rev.100, page 5, precautions section, point 6 "guard against cuff damage by avoiding contact with sharp edges".Unfortunately without the sample we are unable to determine true root cause of this issue.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13194126
• MDR Text Key: 285686252
• Report Number: 3012307300-2022-00307
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/800/075CZ
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 3917063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1