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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF Back to Search Results
Model Number 101/870/085CZ
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
It was reported that the wet nose does not stop properly on the tk connector.
 
Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review was not performed as no fault was found.
 
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Brand Name
PORTEX
Type of Device
TRACHEOSTOMY TUBE AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12919394
MDR Text Key281658973
Report Number3012307300-2021-12157
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019517076233
UDI-Public15019517076233
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101/870/085CZ
Device Lot Number4121517
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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