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

Catalog Number	100/150/070
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex blue line endotracheal cuffed tube was obstructed after a few minutes of being in use, the ventilator alarm sounded for high airway pressures (41cm water) and minimal tidal volumes (60-80ml per breath) were delivered, same with hand ventilation.Oxygen saturations and blood pressure were stable.Doctor attempted to pass a suction catheter into endotracheal tube, which would not advance past 5 cm.At closer inspection of patient's mouth, tube noted to be kinked at the back of the mouth.Tube exchanged for a different endotracheal tube.No further problems.

• 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 55442
• MDR Report Key: 8903979
• Report Number: 3012307300-2019-03836
• Device Sequence Number: 290678
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: 02/17/2024
• Device Catalogue Number: 100/150/070
• Device Lot Number: 19021770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/17/2019
• 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
• Patient Age: 59 YR
• Patient Weight: 62