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

Model Number 100/860/075CZ

Device Problem Leak/Splash (1354)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

It was reported that after the doctor in the intensive care unit inflated and fixed the air bag of the patient's endotracheal intubation, the operating nurse found that the intubation was loose during sputum suction, and the ventilator reported oxygen leakage failure.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 as10001029-003 rev.100, page 4, instruction for use section, point 1: "the integrity of the cuff and inflation system should be checked prior to insertion".Due to fact that cuff leak was discovered during use (not before tracheostomy procedure as required by ifu) it is the most probable that reported failure occurred during use due to contact with sharp edge which is in conflict with instruction for use as10001029-003 rev.100, page 4, 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.

Event Description

It was reported that after the doctor in the intensive care unit inflated and fixed the air bag of the patient's endotracheal intubation, the operating nurse found that the intubation was loose during sputum suction, and the ventilator reported oxygen leakage failure.No patient injury was reported.

Manufacturer Narrative

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 as10001029-003 rev.100, page 4, instruction for use section, point 1: "the integrity of the cuff and inflation system should be checked prior to insertion".Due to fact that cuff leak was discovered during use (not before tracheostomy procedure as required by ifu) it is the most probable that reported failure occurred during use due to contact with sharp edge which is in conflict with instruction for use as10001029-003 rev.100, page 4, 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; yongchuan district; minneapolis, MN 55442
• MDR Report Key: 13194961
• MDR Text Key: 285678486
• Report Number: 3012307300-2022-00313
• 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: 100/860/075CZ
• Device Catalogue Number: 100/860/075CZ
• Device Lot Number: 4068268
• 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: 12/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1