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

Model Number 101/860/075

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one device was returned.Under visual inspection the device appeared to be in good condition.The complaint was confirmed during functional testing as the device cuff would not inflate as it was "badly leaking".A root cause was identified to be a tear in the cuff from manufacturing.A device history record (dhr) review showed there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of products.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.

Event Description

It was reported that air leakage from the cuff occurred.The customer confirmed in advance that there was no air leakage, and said that there was an air leakage from the cuff and that there was also a pinhole in the cuff.Patient involvement unknown.

• Brand Name: PORTEX TUBES BLUSELECT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17430989
• MDR Text Key: 320172511
• Report Number: 3012307300-2023-07649
• 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
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/075
• Device Catalogue Number: 101/860/075CZ
• Device Lot Number: 4259236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1