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

Model Number	101/870/060CZ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Month and year of event have been provided,day is unknown.Expiration date and manufacture date are unknown, no information is available.One used decontaminated tracheostomy device was returned for investigation.The reported issue was confirmed under visual inspection when it was observed that the inflation line was detached from pilot balloon.A lot number was also observed to be printed on the device, which the investigation used to trace the affected assembly line and other lot numbers associated with this line.However the obtained lot number only provides manufacturing line traceability, but does not correspond to a finished goods lot, therefore a review of manufacturing device history records could not be conducted.Although the reported issue was confirmed, a root cause could not be attributed.This issue will continue to be monitored and further actions taken accordingly.
Event or Problem Description
It was reported that when the customer was trying to inflate the cuff after inserting the tube into the patient, the pilot balloon got detached from it.No injury was reported.No additional information is available for this complaint was reported.

• Brand Name: PORTEX TUBES BLUSELECT
• 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: 16593206
• Report Number: 3012307300-2023-02914
• Device Sequence Number: 17474373
• Product Code: BTO
• UDI-Device Identifier: 15019517076196
• UDI-Public: 15019517076196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 101/870/060CZ
• Device Catalogue Number: 101/870/060CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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