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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL ASD, INC. PORTEX® SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/515/075
Device Problems Air Leak (1008); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2018
Event Type  malfunction  
Manufacturer Narrative
This device is same and/or similar to a device approved for distribution in the us.
 
Event Description
It was reported that a portex® suctionaid tracheostomy tube encountered a tear in the cuff and an air leak occurred.The leak occurred during patient use.An unplanned tracheostomy tube change was performed.No permanent injury was reported.
 
Manufacturer Narrative
Three used samples were received for investigation.No holes were detected during visual inspection.Testing was performed and no leak was detected in any of the returned samples.A manufacturing review of a similar device was performed and no discrepancies were found.The complaint could not be confirmed.
 
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Brand Name
PORTEX® SUCTIONAID TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7304674
MDR Text Key101230913
Report Number3012307300-2018-00430
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date01/06/2020
Device Catalogue Number100/515/075
Device Lot Number3521444
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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