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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH SOFT GUEDEL AIRWAY CLEAR PLASTIC; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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TELEFLEX INCORPORATED RUSCH SOFT GUEDEL AIRWAY CLEAR PLASTIC; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/22/2023
Event Type  malfunction  
Event Description
A size 10.0 oral airway was placed in the mouth as a bite block by the certified registered nurse anesthetist (crna) at the conclusion of a general endotracheal anesthetic.As the patient emerged, he bit down forcibly causing the oral airway device to malfunction.The red colored plastic piece at the front of the oral airway disengaged from the rest of the oral airway and shot ~20 feet across the operating room as a projectile.Neither the red or clear plastic pieces fractured.No one was hit by the projectile.The piece did not touch a sterile field.The patient did not have any harm and was extubated without issue.
 
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Brand Name
RUSCH SOFT GUEDEL AIRWAY CLEAR PLASTIC
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key17297380
MDR Text Key318755052
Report Number17297380
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2023
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer07/11/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18250 DA
Patient SexMale
Patient Weight120 KG
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