MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ENDOTRACHEAL CUFFED TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	670190
Medical Device Problem Codes	Inflation Problem (1310); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: france.
Event or Problem Description
Information was received that a smiths medical portex blue line endotracheal cuffed tube did not inflate correctly.No adverse patient effects were reported.

• Brand Name: PORTEX BLUE LINE ENDOTRACHEAL CUFFED TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9927178
• Report Number: 3012307300-2020-02908
• Device Sequence Number: 2817417
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2020

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: No Information
• Device Expiration Date: 09/02/2024
• Device Model Number: 670190
• Device Catalogue Number: 100/150/065
• Device Lot Number: 19090265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1