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

Catalog Number	100/179/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00826.(b)(4).
Event or Problem Description
It was reported that the smiths medical device had observed leaking between the tube and the cuff.This issue was observed after 45 minutes of use.A tube change was required to resolve the issue.No injury was reported.
Additional Manufacturer Narrative
The returned samples consisted of seven portex endotracheal tubes.One sample was received in used conditions and without its original package, and six samples were received in new conditions and with its original closed package.The comments below pertain to the six samples.The returned samples were visually inspected at a distance of 12" to 16" and normal conditions of illumination.No discrepancies were found in the returned samples.With respect to functional testing, the cuffs were inflated using a syringe and the product was submerged under water in order to detect any leakage.No leak was observed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX® IVORY PVC, 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: 7371440
• Report Number: 3012307300-2018-00830
• Device Sequence Number: 19013567
• Product Code: BTR
• UDI-Device Identifier: 15019315022142
• UDI-Public: 15019315022142
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: 100/179/080
• Device Lot Number: 3420228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 07/05/2018
• 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