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	100/166/065
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the slip joint and the tube of a portex® siliconised pvc, oral/nasal soft seal® cuff tracheal tube came off during use of the product.No injury was reported, and the outcome of the event was reported to be full resolution.
Additional Manufacturer Narrative
Upon receipt of the returned product specimen, it was visually examined.One used endotracheal tube was received.Visual inspection revealed no discrepancies.Dimensional inspection was performed, and the device was found to be within specification.The reported observation was not confirmed.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 6567700
• Report Number: 3012307300-2017-01031
• Device Sequence Number: 19113342
• Product Code: BTR
• UDI-Device Identifier: 15019315054075
• UDI-Public: 15019315054075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 100/166/065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1