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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC PORTEX AIRWAY NASOPHARYNGEAL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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SMITHS MEDICAL ASD,INC PORTEX AIRWAY NASOPHARYNGEAL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Hypoventilation (1916); Swelling (2091)
Event Date 07/15/2019
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical portex airway nasopharyngeal was inserted in nostril, after ventilating patient, lower jaw swelling was discovered at that time.When assessing the swelling it was noticed that the nasopharyngeal moved and the device was reported to be under the skin.The tip of the device was not ventilated because of nasal discharge and under subcutaneous tissue.No bleeding was observed with no other reported patient complications.The nasal airway was switched out with no other adverse effects.
 
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Brand Name
PORTEX AIRWAY NASOPHARYNGEAL
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 Key8847243
MDR Text Key152831479
Report Number3012307300-2019-03896
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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