MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/075CZ
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one week after the customer started to use the product, the inflation line got detached from the pilot balloon.Event of the same nature has been recently reported, making this the second occurrence for the same issue (different devices for each occurrence).No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A sample was received for evaluation.It was noticed that during visual inspection, the inflation line was detached from pilot balloon.Thus confirming the reported failure mode.A non-conformance report was created in order to perform a complete cause analysis for the failure mode reported, inflation line detached.The analysis performed in the sample received concluded that although some gaps were detected on the maintenance equipment, this is a minor factor; the occurrence of this failure condition could be caused due to lack of solvent adherence per material properties.Actions were implemented immediately to mitigate this reported condition by improving process steps directly related to factors in process that may infer on this failure: a checklist was added that is used to release the equipment.It includes a verification in the critical alignment tooling that technician needs to do, with the purpose to confirm that tube can be inserted properly and the connection with the balloon is secure, avoiding weak joint between these two components.Also there was an update to the checklist related to the maintenance procedure, that is used to record preventive maintenance.It includes a new method of the maintenance execution verification in order to assure the adherence of the procedure and that samples produced after maintenance keep the quality features consistently.

• Brand Name: PORTEX TUBES BLUSELECT
• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13497470
• Report Number: 3012307300-2022-02997
• Device Sequence Number: 11768670
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 101/870/075CZ
• Device Catalogue Number: 101/870/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/28/2023
• 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