MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE; TRACHEAL TUBE

Model Number	N/A
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
User facility reported that the device was in use with patient for 20 days.According to reporter, air was found leaking from the cuff after 20 days' use.No adverse effects to patient reported.
Additional Manufacturer Narrative
A review of the device history records was not conducted as lot information was not provided.The returned product sample was confirmed to have a cut in the cuff material.To verify that there were no situations or practices that could create/generate the event described by the reporter, an audit of the production floor of product code: 100/860/075 was conducted; note, reported product code: 100/870/075 follows the same manufacturing process as 100/860/075.Production personal were confirmed to be following procedure.The line clearance records were performed, and all training records were current.The reported product fault was not confirmed to be related to a manufacturing issue; however, a corrective action request was implemented to further investigate the root cause of this failure mode.

• Brand Name: PORTEX BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• MDR Report Key: 5442453
• Report Number: 2183502-2016-00228
• Device Sequence Number: 10910855
• Product Code: BTO
• UDI-Device Identifier: 35019315038796
• UDI-Public: 35019315038796
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2016

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: 100/870/075
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2016
• Supplement Report FDA Received Date: 05/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1