MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/810/075

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2023

Event Type  malfunction  

Event Description

It was reported that nurse care found inner cannula was broken after 14 days while it was used on a patient.Inner cannula cleaning by 2% w/v chlorhexidine gluconate in water.Hcp decided that a bronchoscope will be needed to look for any loose parts inside.Adverse patient effects are unknown, and the issue was reported as resolved.

Manufacturer Narrative

H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18636137
• MDR Text Key: 334548218
• Report Number: 3011237704-2024-00033
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315028052
• UDI-Public: (01)15019315028052(17)280217(10)4291174
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/810/075
• Device Catalogue Number: 100/810/075CZ
• Device Lot Number: 4291174
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• 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