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

Model Number	100/199/085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the endotracheal tube was leaking around the bulb.Patient involvement unknown.
Event or Problem Description
Additional information: the cuff was not inflatable.The tube was changed to resolve the issue.No injury to the patient.
Additional Manufacturer Narrative
Other, other text: h3 and h6 - evaluation codes: updated.Device evaluation: five product samples were returned unused and with the original packaging closed.Per visual inspection, no visual defects were detected in the samples, since the samples had the pouch closed.Each sample was opened to perform a leak test.All samples passed.The complaint was not confirmed, and no further analysis was performed.Based on the analysis performed, no root cause could be determined since the complaint was not confirmed as the samples provided do not show any failure mode.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken since the complaint was not confirmed.Email is: regulatory.Responses@icumed.Com.

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED 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: 16811595
• Report Number: 3012307300-2023-04554
• Device Sequence Number: 2920504
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/29/2024

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: 100/199/085
• Device Catalogue Number: 100/199/085
• Device Lot Number: 4262329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 11/26/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/04/2023; 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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