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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL OVASSAPIAN AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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TELEFLEX MEDICAL OVASSAPIAN AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
Catalog Number BD6075
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Failure to Disconnect (2541)
Patient Problems Dyspnea (1816); Swelling (2091)
Event Date 12/25/2013
Event Type  No Answer Provided  
Event Description
This patient presented with shortness of breath and swelling of the tongue.He required emergent fiberoptic intubation.After the airway was secured, the ovassapian airway was not removed and was not visualized due to the protuberant tongue.Six days later, the airway was removed at the time of the patient's elective extubation.The airway was not detected on chest x-ray and may have potentially contributed to the patient's need for re-intubation and ultimate tracheostomy.At the internal review, recommendations were to have a discussion with the manufacturer to determine if the product may be improved to be more easily detected (i.E., color coding of the airway or marking with a radio opaque indicator that would be detected on x-ray).Although this is a very unique event, we would like to provide some assurance that this is not likely to happen again.
 
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Brand Name
OVASSAPIAN AIRWAY
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
po box 12600
durham NC 27709
MDR Report Key3586784
MDR Text Key16779297
Report Number3586784
Device Sequence Number1
Product Code CAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? *
Device Operator Invalid Data
Device Catalogue NumberBD6075
Device Lot Number02E1300356
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2014
Event Location Hospital
Date Report to Manufacturer01/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT WAS CRITICALLY-ILL IN THE ICU.; OTHER
Patient Age65 YR
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