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

Model Number 101/860/075CZ

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

One device was returned for investigation.Product was visually inspected with no defects found.It was then connected to an obturator which was smoothly inserted with no obstruction.The cuff was tested and no air leak was found.No fault was found with the device so no dhr review was done along with no root cause needing to be done.

Event Description

It was reported that the customer attempted to attach a non-smiths' suction catheter to the trach tube.Only a part of the catheter was able to be inserted into the trach and was easily falling out.No patient injury.No additional information is available for this complaint.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 12513002
• MDR Text Key: 272702002
• Report Number: 3012307300-2021-09531
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• Combination Product (y/n): N
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1