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

Model Number	101/800/100
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	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the pilot balloon was replaced every two weeks.The tube currently in use was scheduled to be replaced the next day, but the pilot balloon fell off.Therefore, the tube was replaced as an emergency one day earlier than planned.It was reported no health hazards or adverse effects occurred.
Additional Manufacturer Narrative
One used decontaminated device was received.Per visual inspection, the inflation line was detached from the pilot balloon.The complaint was confirmed, and no further analysis was performed.A root cause has not been established.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue is being monitored, and further actions taken accordingly.
Additional Manufacturer Narrative
D4: insufficient information was provided to be able to determine the full udi.Udi related data quality updates only.

• Brand Name: PORTEX BLU SELECT 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: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17856936
• Report Number: 3012307300-2023-09489
• Device Sequence Number: 16963634
• Product Code: BTO
• UDI-Device Identifier: 15019517076059
• UDI-Public: 15019517076059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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: 101/800/100
• Device Catalogue Number: 101/800/100CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023; Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/03/2023; 08/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown