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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® INTUBATION STYLET; STYLET, TRACHEAL TUBE
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SMITHS MEDICAL ASD, INC. PORTEX® INTUBATION STYLET; STYLET, TRACHEAL TUBE Back to Search Results
Catalog Number 100/120/100
Device Problem Flaked (1246)
Patient Problem No Information (3190)
Event Date 11/11/2017
Event Type  Injury  
Event Description
Information was received indicating that the coating to the smiths medical portex® intubation stylet stayed within the tube upon withdrawal during intubation.There was reported unknown adverse health outcome.
 
Event Description
Photograph of the returned device indicates the device may not be a smiths medical device.Additional information received from the customer stated the device may be a teleflex product, but they are not sure.
 
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Brand Name
PORTEX® INTUBATION STYLET
Type of Device
STYLET, TRACHEAL TUBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING SA DE CV
carretera miguel alemán km 21.
parque industrial monterrey
apodaca nl, nl CP 66 603
MX   CP 66603
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key7131390
MDR Text Key95315907
Report Number3012307300-2017-02700
Device Sequence Number1
Product Code BSR
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number100/120/100
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2018
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 Initial
Patient Sequence Number1
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