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

Model Number	100/189/085
Medical Device Problem Code	Disconnection (1171)
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
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Fifty-four (54) samples were returned from part number 100/189/075; sample was returned in unused conditions within original package.Visual inspection found the connector had properly assemble inside tube for 54 samples received.No other analysis was performed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.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; minneapolis, MN 55442
• MDR Report Key: 15154283
• Report Number: 3012307300-2022-14402
• Device Sequence Number: 5197072
• Product Code: BTR
• UDI-Device Identifier: 15019315059551
• UDI-Public: 15019315059551
• 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): 06/12/2023

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 Expiration Date: 07/08/2024
• Device Model Number: 100/189/085
• Device Catalogue Number: 100/189/085
• Device Lot Number: 3835859
• 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: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• 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