MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GUEDEL AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Catalog Number DYND60606

Device Problems Break (1069); Component Falling (1105); Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2015

Event Type  malfunction  

Event Description

During induction of general anesthesia a 90mm duedel airway was placed in the patient's airway.During the course of reversal, the patient bit down and the yellow plug of the airway became loose and popped out and landed on the patient's lips.The piece was retrieved by the attending anesthesiologist.It is the fear of the physician that it could happen again landing in a patient's throat obstructing the airway.

• Brand Name: GUEDEL AIRWAY
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5385176
• MDR Text Key: 36621943
• Report Number: 5385176
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: DYND60606
• Device Lot Number: 18315050003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR