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

Model Number	100/189/090
Medical Device Problem Codes	Disconnection (1171); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blue 15mm connector kept disconnecting from the tracheal tube.The tip was not deep enough inside the tube and just disconnects.No clinical consequence, issue occurred upon opening.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the samples consisted of 54 units that were returned for investigation.The returned samples were received in unused conditions within the original package.The returned samples were visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.Per visual inspection, connector had properly assembled inside tube for 54 samples received.Based on the analysis conducted on the samples provided, the connector was deep enough inside the tube, therefore the reported failure mode was not confirmed.No other analysis was performed.No fault was found with the device as the reported issue/failure mode was not verified or confirmed.No root cause was determined, and no corrective actions were required since the complaint was not confirmed.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 b10010579, as a result of warning letter cms# 617147.

• 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; minneapolis, MN 55442
• MDR Report Key: 15154286
• Report Number: 3012307300-2022-14403
• Device Sequence Number: 19360361
• Product Code: NTR
• UDI-Device Identifier: 15019315059568
• UDI-Public: 15019315059568
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/189/090
• Device Catalogue Number: 100/189/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown