MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CUFFED IVORY ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR) PRODUCT CODE: BTR

Catalog Number	100/179/060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: (b)(6).
Event or Problem Description
Information was received that during the use of a smiths medical portex cuffed ivory endotracheal tube, "the customer noticed blood leaked somewhere in the tube".No adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation: three photographs were received for evaluation.In addition, one portex tracheal sample was received in used condition without its original packaging.Immediate visual inspection of the photos showed blood in the lumen and in the cuff.However, no discrepancies were observed when visualizing 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 and no issues, including leaks were found.Operator training records were reviewed to ensure operators are trained in bell-out, cuff inflation, and pressure decay tests.No discrepancies were found.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and investigation, the complaint allegation was not confirmed.No fault was found with the returned sample.

• Brand Name: PORTEX CUFFED IVORY ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR) PRODUCT CODE: BTR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8580695
• Report Number: 3012307300-2019-02488
• Device Sequence Number: 1731578
• Product Code: BTR
• UDI-Device Identifier: 15019315022104
• UDI-Public: 15019315022104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Catalogue Number: 100/179/060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/04/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1