Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. PORTEX CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/860/0751
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2018
Event Type  malfunction  
Event Description
Information was received that the portex tracheostomy tube had a cuff that deflated easily after filling air in it.No reported adverse effects.
 
Manufacturer Narrative
One used tracheostomy tube was received for device evaluation.Visual inspection found no discrepancies or anomalies.Functional testing, using a syringe to inflate the cuff, was performed to test for leakage.The device was submerged under water, and a leak was detected between the valve and pilot balloon.This investigation found a bonding issue and the root cause was attributed to manufacturing.An inconsistency was identified in the application of solvent due to a damaged pump used in manufacturing.This damaged pump has been replaced.Additionally, to raise awareness and lessen the chances of its recurrence, a quality alert was posted to all personnel involved with this product's manufacture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7566882
MDR Text Key110034943
Report Number3012307300-2018-02043
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number100/860/0751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Was the Report Sent to FDA? No
Date Manufacturer Received09/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-