MAUDE Adverse Event Report: ST PAUL PORTEX; OROPHARYNGEAL AIRWAY

Model Number	100/322/100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for investigation.
Event or Problem Description
It was reported that the patient was in the recovery room, not yet awake but was pushing on the guedel cannula in their mouth.The red tip of the cannula, which is mobile, ended up in the patient's mouth which caused a risk of swallowing or choking on it.The customer stated the cannula did not appear to be damaged.No adverse health outcomes were reported for the patient.

• Brand Name: PORTEX
• Common Device Name: OROPHARYNGEAL AIRWAY
• 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: 13366513
• Report Number: 3012307300-2022-01890
• Device Sequence Number: 5969550
• Product Code: CAE
• UDI-Device Identifier: 15019315071430
• UDI-Public: 15019315071430
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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 Model Number: 100/322/100
• Device Catalogue Number: 100/322/100
• Device Lot Number: 2107021206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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