MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/075
Medical Device Problem Codes	Deflation Problem (1149); Pressure Problem (3012)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	07/01/2022
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 additional reportable information becomes available.
Event or Problem Description
It was reported that there was cuff deflation and malfunctioning of a pressure valve.Ventilator associated pneumonia was reported.Additional information was requested; however, no further information was received.
Additional Manufacturer Narrative
Two photos were included in agile attachments for evaluation.Based on the photos received, the reported failure mode could not be detected; the complaint was not confirmed.No other analysis was performed.Based on the photos received, the reported failure mode could not be detected.No root cause was determined, and no corrective actions were required since the complaint was not confirmed.No fault was found as no product was returned for analysis.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; thousand lights; minneapolis, MN 55442
• MDR Report Key: 15288169
• Report Number: 3012307300-2022-16102
• Device Sequence Number: 2329084
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: 15019315059537
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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 Expiration Date: 02/01/2026
• Device Model Number: 100/189/075
• Device Catalogue Number: 100/189/075
• Device Lot Number: 4100440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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: Life Threatening
• Patient Sex: Unknown