MAUDE Adverse Event Report: SMITHS MEDICAL, ASD INC. PORTEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/870/080

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The day of the event date is unknown.Only the month (b)(6) and year (2020) are known.Customer facility phone number: (b)(6).Company representative phone number: (b)(6).

Event Description

It was reported that the cuff component of the blue line ultra (blu) tracheostomy tube was deflating too easily.No patient injury or complications were reported in relation to this event.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL, ASD INC.; 6000 nathan lane; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane; minneapolis, mn
• MDR Report Key: 10461508
• MDR Text Key: 204626714
• Report Number: 3012307300-2020-06859
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3913697
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1