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

Model Number	100/897/080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number, expiration date and h4: device manufacture date is unknown, as invalid lot number provided by the customer.No product was returned therefore the manufacturer was unable to confirm the reported complaint.A device history record (dhr) review could not be performed as no valid lot number was provided.If the product is returned, the manufacturer will reopen the complaint for further investigation.
Event or Problem Description
It was reported that the white hub detached from the tube 8 days after trach change.The patient desaturated and had to have an urgent trach change done to resolve the issue.This did not cause any injury to the patient.The reported lot number was not a valid lot number for the device.

• 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: 16879444
• Report Number: 3012307300-2023-05219
• Device Sequence Number: 5822574
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/897/080
• Device Catalogue Number: 100/897/080
• Device Lot Number: 277203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/05/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown