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

Model Number 100/322/080

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Reportable event was corrected to malfunction and not death.

Event 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.

Event Description

Corrective information to be sent in h10.

Manufacturer Narrative

Corrected data: h1 a correction has been made as this is a malfunction and no death occurred.This is an error on the submitter end.

• Brand Name: PORTEX
• Type of Device: INTUBATON
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10397734
• MDR Text Key: 202595743
• Report Number: 3012307300-2020-08120
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15019315071416
• UDI-Public: 15019315071416
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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
• Device Operator: 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 Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention