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

Model Number 101/860/080CZ

Device Problem Insufficient Information (3190)

Patient Problem Dyspnea (1816)

Event Date 09/01/2020

Event Type  Injury  

Event Description

Information was received indicating that a patient with a smiths medical portex bluselect tracheostomy tube was having complaints of difficulty breathing.Subsequently, the tube was changed out with a non-smiths medical tube.The symptoms were reported to then get better with no further adverse effects.

Manufacturer Narrative

Other text: h10? device evaluation results: one portex bluselect tracheostomy tube was returned for investigation in used condition.Under visual inspection the sample appeared to be in good condition.No defect or damage was observed.Difficult breathing which is claimed by customer might be caused by a cuff leak.During 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.We repeated this inflation test on returned sample and we can confirm that cuff was still fully inflated after 12 hours.No fault was found with the returned product.

• 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
• MDR Report Key: 10623620
• MDR Text Key: 209758152
• Report Number: 3012307300-2020-10086
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention