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

Model Number 101/815/070

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date is unknown, no product information has been provided to date.No product was returned and are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review could not be performed as the lot number is unknown.

Event Description

It was reported that during the use of a trach, it was discovered that the trach was missing from the unopened outside box, and only instructions were found inside.The doctor searched for another trach on the shelf, but found the same situation.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16622298
• MDR Text Key: 312069757
• Report Number: 3012307300-2023-03047
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517077346
• UDI-Public: 15019517077346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/815/070
• Device Catalogue Number: 101/815/070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1