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

Model Number 101/860/070CZ

Device Problem Disconnection (1171)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was unable to be completed as no lot information was provided.

Event Description

It was reported that, immediately upon use, the inflation line was detached from the device.There was no patient injury reported.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source is unknown.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.

• Brand Name: PORTEX
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13688732
• MDR Text Key: 286741498
• Report Number: 3012307300-2022-04372
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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: 05/04/2022

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: 101/860/070CZ
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/05/2022
• 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