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

Model Number	101/870/070CZ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review under visual inspection we noticed that inflation line was detached from pilot balloon and then repaired as described in complaint description.The device was assembled in tijuana's manufacture therefore secondary investigation object was created and complaint sample was resent to this site.Similar customer complaints have been recently received therefore internal non-conformity report (ncr) was created with purpose to evaluate this issue.The returned sample was visually inspected at 12 to 16 inches and normal conditions of illumination according site visual inspection procedure.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus, the failure mode reported was confirmed.The customer comments that he decided to join both components using adhesive.Non-conformance report (ncr) was created on 03-nov-2021, in order to perform a complete cause analysis for the failure mode reported for inflation line detached.The analysis performed in the sample received concluded that although some gaps detected on the maintenance equipment during the investigation this is a minor factor.The root cause of this occurrence failure condition could be caused due to lack of solvent adherence per material properties.To expand this investigation an ncr was opened on 03-nov-2020, as well where implemented immediate actions to mitigate this reported condition by improving process steps direct related with factors in process that may infer on this failure: the checklist to procedure, that is used to released the equipment, will include 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 join between these two components.Update checklist related to procedure used to record preventive maintenance to include a new method of the maintenance execution verification in order to assurance the adherence of the procedure and that samples produced after maintenance keep the quality features consistently and stably.
Event or Problem Description
It was reported that after having the patient in a bath, the customer laid the patient down in the bed.The customer then noticed the pilot balloon was detached from the product.She then bonded the pilot balloon to the inflation line by herself using adhesive.No patient injury was reported.

• Brand Name: PVC - 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16873129
• Report Number: 3012307300-2023-05108
• Device Sequence Number: 12117595
• Product Code: BTO
• UDI-Device Identifier: 15019517076202
• UDI-Public: 15019517076202
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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: 101/870/070CZ
• Device Catalogue Number: 101/870/070CZ
• Device Lot Number: 4073762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown