MAUDE Adverse Event Report: ST PAUL PORTEX GUEDEL AIRWAY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number	100/322/080
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the green ring came out of the tube and was found inside of patient's mouth.No injury observed.
Additional Manufacturer Narrative
Other, other text: all information related to this complaint was sent to the supplier.A product sample was received for evaluation and was forwarded to the supplier for analysis.An internal scar has been opened and should additional information be returned pertinent to the investigation a supplemental report will be filed.

• Brand Name: PORTEX GUEDEL AIRWAY
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14186742
• Report Number: 3012307300-2022-06778
• Device Sequence Number: 5755935
• Product Code: CAE
• UDI-Device Identifier: 15019315071416
• UDI-Public: 15019315071416
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: 100/322/080
• Device Catalogue Number: 100/322/080
• Device Lot Number: 2101020198
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown