MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; INTUBATON

Model Number	100/322/080
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex airway guedel oropharyngeal when patient was coughing, the green tip of the guedel airway disconnected.They had to change the device.
Additional Manufacturer Narrative
Other, other text: correction- no patient death reported.

• Brand Name: PORTEX
• Common Device Name: INTUBATON
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10396942
• Report Number: 3012307300-2020-08103
• Device Sequence Number: 4092626
• 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: unknown
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 100/322/080
• Device Catalogue Number: 100/322/080
• Device Lot Number: 1910022172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention