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

Model Number 100/322/080

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that the green ring came out of the tube and was found inside of patient's mouth.No injury observed.

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
• Type of Device: 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
• MDR Text Key: 289874692
• Report Number: 3012307300-2022-06778
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15019315071416
• UDI-Public: 15019315071416
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1