MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BLUE LINE ULTRA® SUCTIONAID® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/875/070
Medical Device Problem Codes	Suction Problem (2170); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction link of a portex® blue line ultra® suctionaid® tracheostomy tube would not work.The fault was noticed immediately upon use with the patient.No injury was reported.
Additional Manufacturer Narrative
One portex® blue line ultra® suctionaid® tracheostomy tube was returned for analysis in used condition.The connector was noted to be occluded / covered by plastic upon visual exam.It was noted that the plastic covering the connector was from the same material as the connector.Relevant documents were reviewed and deemed adequate (mp trachy (b)(4) blus tracheostomy tube-bond connector to suction line tube; qp trachy (b)(4) trachy blue line assembly and packaging).An audit of the production floor was conducted by the quality engineer was performed.Line clearance records, training records and production personnel are following the procedure mp trachy (b)(4) blus tracheostomy tube-bond connector to suction line tube were reviewed with no discrepancies.Flow testing of (b)(4) units were audited detecting occlusions; confirming complaint.Based on the evidence, the possible root cause is from supplier from the following findings: the connector was received occluded from the supplier; lack of detection by production personnel.

• Brand Name: PORTEX® BLUE LINE ULTRA® SUCTIONAID® TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7441870
• Report Number: 3012307300-2018-01188
• Device Sequence Number: 1421873
• Product Code: BTO
• UDI-Device Identifier: 15019315047350
• UDI-Public: 15019315047350
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: No Information
• Device Catalogue Number: 100/875/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1