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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT; OROTRACHEAL INTUBATION GUIDE KIT
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT; OROTRACHEAL INTUBATION GUIDE KIT Back to Search Results
Catalog Number F031-61
Device Problem Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 08/12/2019
Event Type  Injury  
Event Description
Information was received that while smiths medical portex laryngotracheal anesthesia kit was in use, the cannula was noted to be cracked and broken while intubating the patient.While using a fiberscope to place et tube, the broken tip was in the lung.It was also reported that the doctor installing the laryngotracheal cannula tried to bend it/shape it prior to using.Incident is reported to be ongoing.
 
Manufacturer Narrative
Information was reported stating, " they need to anesthetize the patient and move patient to another hospital where they could do a bronchoscopy." this incident is life threatening, and this reported information is classified as medical intervention.B1: corrected information.
 
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Brand Name
SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT
Type of Device
OROTRACHEAL INTUBATION GUIDE KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key9327674
MDR Text Key174181442
Report Number3012307300-2019-06242
Device Sequence Number1
Product Code OGK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberF031-61
Was Device Available for Evaluation? No
Date Manufacturer Received08/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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