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

Model Number	101/815/070
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012307300-2023-03047
• Device Sequence Number: 20659440
• Product Code: BTO
• UDI-Device Identifier: 15019517077346
• UDI-Public: 15019517077346
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown