MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number 8.00MM

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) would not hold pressure.The customer confirmed in a pre-use check that the product worked properly.He then started to use it with 30 mmhg of air pressure applied to its cuff.However, in 30 minutes or so, the pressure decreased to 7-10 mmhg.As this event was repeatedly observed, he changed the product to another one in one (1) day after starting to use the first one.No patient injury.

Manufacturer Narrative

Other, other text: correction: b1 and h1.Device evaluation: one portex tubes blue line ultra (blu) was returned for analysis.The returned sample was visually inspected at 12? to 16? and normal conditions of illumination, no failures were found.The cuff and pilot balloon of the returned sample were inflated using a syringe with air, then the product was immersed in the water in order to detect any leakage.No air bubbles came out of the cuff or from the pilot balloon.The cuff tear occurs during tracheostomy procedure due to contact with sharp edge.He occurrence for this failure condition could be caused by: cuff evacuation unit and fixture for place trachy tubes, fit cuff inflation and deflation test failure by insufficient thf pvc cement, fit cuff inflation and deflation test failure, improper assembly and partial inflation cuff.Detection procedures include 100 percent visual inspection and 100 percent inflation tests after 12 hrs of resting, cuff has inflated and ensures no deflation has occurred.Also by reinflation tests after 6hrs of resting and 100 percent visual inspection as well as pressure testing.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10979240
• MDR Text Key: 220628584
• Report Number: 3012307300-2020-12247
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (y/n): N
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8.00MM
• Device Catalogue Number: 100/870/080
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/10/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention