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

Model Number	101/818/060
Medical Device Problem Codes	Component Incompatible (1108); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient says that the trach tube will not fit correctly in the wedge.The customer said the tube looked like the trach is for a child.No report of patient injury.Unknown lot number.
Additional Manufacturer Narrative
D4: expiration date and h4: manufacture date are unknown, no information is available based on reported lot number.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: h6 codes updated.No device was returned for evaluation.Two (2) pictures were used for the investigation.Both images showed the device in expected form with no deviations.No device issue could be found from the two pictures and without the physical device, no functional testing could be done.Root cause not able to be determined.No lot number was provided, no device history review able to be done.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16899386
• Report Number: 3012307300-2023-05434
• Device Sequence Number: 6819326
• Product Code: BTO
• UDI-Device Identifier: 15019517077520
• UDI-Public: 15019517077520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: Lay User/Patient
• Device Model Number: 101/818/060
• Device Catalogue Number: 101/818/060
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown