MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLU SELCT SUCTIONAID CUFFED NONFENESTRATED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/090
Medical Device Problem Codes	Disconnection (1171); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pilot balloon became detached during patient use.The tracheostomy tube was inserted on september 15th.The patient was removed from ventilator on september 19th.Moved to a controlled oxygen mask.Nurse visited patient room on october 2nd and found the pilot balloon deflated and disconnected from inflation line.Doctor replaced the tube and light blown colored liquid (gastric fluid) could be aspirated.Patient injury was unknown.However accidental swallowing to the trachea possibly occurred on the patient.
Additional Manufacturer Narrative
Other text: d3,g1, and g2 email is: regulatory.Responses@icumed.Com.Device evaluation: one device was returned for investigation.Under visual inspection we noticed that inflation line was detached from pilot balloon as reported by customer.The complaint was confirmed.What caused the failure of the supplied item could not be established.Dhr review not completed as the issue is not lot specific.The complaint issue continues to be monitored and suitable actions will be taken as appropriate.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: PORTEX BLU SELCT SUCTIONAID CUFFED NONFENESTRATED
• 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: reed covert
• MDR Report Key: 18724827
• Report Number: 3012307300-2024-10011
• Device Sequence Number: 15040350
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: 15019517076172
• 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): 02/16/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 101/860/090
• Device Catalogue Number: 101/860/090CZ
• Device Lot Number: 4276630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic