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

Model Number 101/860/080CZ

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Expiration date and device manufacture date is unknown.No product information has been provided to date.No product was returned for evaluation.No lot number was provided; therefore, no review of manufacturing device history records could not be conducted.During the manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.History of internal non-conformance review (ncr) showed that there was internal nonconformity report raised due to cuff tear which was found after inflation test.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.No trend of confirmed complaints in relation with this issue was identified.With no lot number reported, we are unable to verify if reported lot number was manufactured prior to or after corrective actions.Based on the available information, the reported issue could not be confirmed, or root cause attributed.No actions have been taken.

Event Description

It was reported that when air was placed in the cuff, it would not be inflated.Event occurred during pre-test.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

• Brand Name: PORTEX BLUSELECT 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 16539994
• MDR Text Key: 311291015
• Report Number: 3012307300-2023-02426
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1