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

Model Number 100/597/080CZ

Device Problem Complete Blockage (1094)

Patient Problem Hypoxia (1918)

Event Date 07/05/2021

Event Type  malfunction  

Event Description

Information received a smiths medical tracheostomy|pvc - portex tubes pdt uniperc required intervention to preclude serious impairment.On (b)(6) 2021 0800hrs noticed blue lever (locking mechanism) on trachesotomy was partially lifted and unlocked.Tracheostomy remained in good position, nil issues with ventilation.Vital signs nad.( no actual distress) re-locked.No further issue reported until.Decannulated (b)(6) 2021.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Locking mechanisms were tested (locked and unlocked several times) and no problem was found.Blue locking levers were correctly assembled with adjustable flanges, when closed flanges were firmly attached to tracheostomy tube, when unlocked flanges were smoothly moving.No fault was found with the device regarding the reported customer problem.The cause of the reported problem could not be determined.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12276479
• MDR Text Key: 265038189
• Report Number: 3012307300-2021-08059
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/597/080CZ
• Device Catalogue Number: 100/597/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1