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

Model Number BLU TRACHY 8.5MM S/SEAL CUFF 10/BX

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information received a smith medical malfunctioned during the change of the tracheostomy tube, a rupture from the cuff was observed.It caused leakages.This incident occured twice with the same patient.No clinical consequences for the patient.They had to use another tracheostomy tube.

• 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: david halverson ; 6000 nathan lane north; buroparc rive gauche; minneapolis, MN 55442
• MDR Report Key: 10296281
• MDR Text Key: 199515984
• Report Number: 3012307300-2020-07422
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BLU TRACHY 8.5MM S/SEAL CUFF 10/BX
• Device Catalogue Number: 100/812/080CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention