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

Model Number 101/858/090

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that the rn removed the inner cannula to exchange a new one at shift changes.Part of inner cannula broke while rn removed it so the inner canular was stuck , rn was unable to remove the broken inner cannula from patient tracheostomy.Th issue was resolved by replacing the inner cannula safely.There was no patient injury reported.

Manufacturer Narrative

One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product was received for evaluation.The upper ring is broken, thus failure mode is confirmed; however, despite able to confirm the failure mode reported, it is not possible relate defect with process manufacturing.The root cause of the complaint was not able to be determined.No corrective actions were taken since the complaint was not relate to manufacturing process.

Event Description

Additional information indicated that a medical intervention was required to replace the new inner cannula safely.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• 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; minneapolis, MN 55442
• MDR Report Key: 14014155
• MDR Text Key: 288601175
• Report Number: 3012307300-2022-05832
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517077889
• UDI-Public: 15019517077889
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/858/090
• Device Catalogue Number: 101/858/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/06/2023
• 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
• Patient Outcome(s): Required Intervention