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

Model Number 101/860/080CZ

Device Problem Premature Separation (4045)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Information was received that during the use of the product, the inflation line got detached from the pilot balloon.No patient injury.No further information.

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.During visual inspection, it was noticed that inflation line was detached from pilot balloon.A product sample was received for evaluation.The returned sample was visually inspected under normal conditions of illumination according to procedure.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus, the failure mode reported is confirmed.A non-conformance report was created 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 cause of this failure condition could be caused due to lack of solvent adherence per material properties.Also, during the non-conformance report actions were implemented to mitigate this reported condition by improving process steps directly related with factors in the process that may infer on this failure: a checklist to the procedure that is used to release 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 joint between these two components.Also, updating the maintenance procedure to record preventive maintenance to include a new method of the maintenance execution verification in order to assure adherence to the procedure and that samples produced after maintenance keeps the quality features consistently.

• Brand Name: PORTEX TUBES BLUSELECT
• Type of Device: 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; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 13169937
• MDR Text Key: 283261825
• Report Number: 3012307300-2022-00127
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• 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