MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® ENDOBRONCHIAL DOUBLE LUMEN; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	198-32L
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during use of a portex® endobronchial double lumen, the customer could not perform a single-lung ventilation because the bronchial cuff (a blue cuff) was not properly sealed.No patient injury.
Additional Manufacturer Narrative
One portex® endobronchial double lumen was received for evaluation.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.No discrepancies were found in the returned sample.The cuff of the returned sample was inflated using a syringe and the product was submerged under water in order to detect any leakage.No discrepancies were found.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.No root cause was determined since the complaint was not confirmed.No issues were found with the smiths healthcare facility.

• Brand Name: PORTEX® ENDOBRONCHIAL DOUBLE LUMEN
• 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: 7396091
• Report Number: 3012307300-2018-00662
• Device Sequence Number: 19136639
• Product Code: BTR
• UDI-Device Identifier: 35019315058602
• UDI-Public: 35019315058602
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: 08/10/2020
• Device Catalogue Number: 198-32L
• Device Lot Number: 3475549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1