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

Model Number 100/810/060CZ

Device Problem Leak/Splash (1354)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported the balloon of the device could not be inflated, while in use with the patient.No patient injury was reported.

Manufacturer Narrative

Device evaluation (b)(6)(2022): the investigation of the complaint was limited because no sample was returned.Due to fact that cuff leak was discovered during use (not before tracheostomy procedure during pretesting) it is the most probable that reported failure occurred due to contact with sharp edge which is in conflict with instruction for use as10001031-002 rev.100, page 5, precautions, point 6: "guard against cuff damage by avoiding contact with sharp edges".Unfortunately without the sample we are unable to determine the 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.No trend of confirmed complaints in relation with this issue was identified.

• Brand Name: PORTEX
• 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; guangzhou; minneapolis, MN 55442
• MDR Report Key: 13583415
• MDR Text Key: 288996149
• Report Number: 3012307300-2022-03900
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2022

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: 100/810/060CZ
• Device Catalogue Number: 100/810/060CZ
• Device Lot Number: 3958291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male