MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Catalog Number	198-32L
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical portex® endobronchial tube was kinked while in use with the patient.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Corrected information: the available information suggests that there was actually no patient involvement in the reported incident because the device malfunction was found prior to use on a patient during a pre-use check.The coded hazard situation (rmd-10001706.100-occlusion/restriction) should have been rmd-10001706.100-occlusion/restriction-haz.Sit.21- compromised treatment due to obstructed/constricted tube or airline.This hazard situation indicates that this complaint is not reportable to the fda.The reported also does not indicate that a kinked tube would likely cause or contribute to a death or serious injury if the malfunction were to recur.Additionally, the device at the time of the incident was not life sustaining as the fault was detected prior to use with a patient.Therefore, this complaint is not reportable as a life sustaining malfunction or product problem malfunction.

• Brand Name: PORTEX® ENDOBRONCHIAL TUBES
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8092591
• Report Number: 3012307300-2018-08285
• Device Sequence Number: 11114445
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: 198-32L
• Device Lot Number: 3593120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1