MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SILICONISED PVC, ORAL/NASAL SOFT SEAL® CUFF TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/166/080
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the event occurred in "the past 4 weeks".Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a portex® siliconised pvc, oral/nasal soft seal® cuff tracheal tube kinked during use.The issue was observed after less than 12 hours from the tube insertion.No patient injury was reported.
Event or Problem Description
It was further reported that the endotracheal tube kinked after being patient use for 11 hours.The endotracheal tube was replaced.

• Brand Name: PORTEX® SILICONISED PVC, ORAL/NASAL SOFT SEAL® CUFF TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6498131
• Report Number: 3012307300-2017-00860
• Device Sequence Number: 1391369
• Product Code: BTR
• UDI-Device Identifier: 15019315054129
• UDI-Public: 15019315054129
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: Health Professional
• Device Catalogue Number: 100/166/080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1