MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/870/080

Device Problems Fluid/Blood Leak (1250); Unintended Deflation (4061)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 01/29/2023

Event Type  Injury  

Manufacturer Narrative

Device evaluation: one device was received without its original packaging.During leak testing the sample was deflated (leak was identified under water to be tear in cuff).Since the cuff leak was observed after approximately 14 days in use.The most probable root cause was due to contact with a sharp edge which is in conflict with instruction for use.A review of the device history records shows there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of product.No actions taken at this time.

Event Description

It was reported that after 14 days in use, during suction the cuff sometimes deflated and eventually fluid got into the cuff.The tube was replaced.No injury reported.No additional information is available for this complaint.

• Brand Name: PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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; minneapolis, MN 55442
• MDR Report Key: 16532893
• MDR Text Key: 311208982
• Report Number: 3012307300-2023-02326
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4288994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention