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

Model Number 101/860/075CZ

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that the product was indwelled in the patient from (b)(6) to (b)(6).During the use of it (during that time), a spontaneous removal of the product occurred.The customer then checked it and noticed the inflation line was detached from the pilot balloon.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.One used decontaminated sample was returned for investigation without its original packaging.The returned sample was visually inspected under normal conditions of illumination according to procedure.During visual inspection, it was noticed that the inflation line was detached from pilot balloon and a lack of solvent was detected; thus, the failure mode reported is confirmed.To expand this investigation a non conformance was opened to implement immediate actions to mitigate this reported condition by improving process steps directly related with factors in process that may infer on this failure: the checklist to the manufacturing procedure, that is used to release the equipment.This will include 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 and the checklist related to another procedure was updated to record preventive maintenance.Including 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.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12805630
• MDR Text Key: 280754770
• Report Number: 3012307300-2021-11149
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/075CZ
• Device Catalogue Number: 101/870/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1