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

Model Number	101/860/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 tube was inserted after tracheostomy.There was voice leakage, and when checking the air several times, it was gradually decreasing.Replaced the tube with a new one.Adverse effects are unknown.
Additional Manufacturer Narrative
Additional information: h2, h3, h6 - health effects codes updated.One device was received for evaluation without its original packaging, inside a plastic bag in decontaminated conditions.Per visual inspection, no damage or other defects were detected on the sample.No leak was found in the product returned.Leaking during use was not confirmed.The product's device history records (dhr) were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.A device history record (dhr) review cannot be performed because a lot number was not provided.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following:(b)(6).
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 SUCTIONAID CUFFED TRACHEOSTOMY
• 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: 18057085
• Report Number: 3012307300-2023-10178
• Device Sequence Number: 20545370
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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): 08/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: No
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 03/22/2024; Not provided
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 04/11/2024; 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