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

Model Number 526070

Device Problems Accessory Incompatible (1004); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

Information was received that a smiths medical portex tracheostomy replacement inner cannula would not clip into the patient's tracheostomy tube as the snap was not holding.There were no adverse patient effects.

• Brand Name: PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road, hythe; kent ct21 6jl; kent, ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8528645
• MDR Text Key: 142395345
• Report Number: 3012307300-2019-02112
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688041135
• UDI-Public: 10351688041135
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/04/2023
• Device Model Number: 526070
• Device Catalogue Number: 526070
• Device Lot Number: 3739646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE
• Patient Age: 3 MO