MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number 101/860/075CZ

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the pilot balloon got detached from the inflation line.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One used decontaminated sample was returned for investigation without its original packaging.The returned sample was visually inspected at 12 to 16 inches and normal conditions of illumination according to site visual inspection.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus, the failure mode reported is confirmed.The root cause was not determined.Action taken: to expand this investigation a non conformance(ncr) was open, as well immediate actions was implemented to mitigate this reported condition by improving process steps directly related with factors in process that may infer on this failure.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13122248
• MDR Text Key: 283684513
• Report Number: 3012307300-2021-13525
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1