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

Model Number 100/860/080

Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that the portex tubes blue line ultra worked properly during the pre-use check.However, after intubating it into the patient, when the customer was about to check the cuff's air pressure, the syringe became unable to be connected to the product.There was no patient injury reported.

Manufacturer Narrative

Other text: h10 ? device evaluation results: one portex tracheostomy tubes (blue line ultra) was returned for investigation in used condition.Visual inspection revealed that valve was deformed and the syringe was unable to connect.The customer reported product problem was therefore confirmed.The investigation concluded that the product was damaged after it left the manufacturing facility.User damage to the product was established as the root cause of the product problem.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10880950
• MDR Text Key: 217659986
• Report Number: 3012307300-2020-11667
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• 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: 02/22/2021

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: No Information
• Device Model Number: 100/860/080
• Device Lot Number: 3977823
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/21/2020
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1