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

Device Problems Suction Problem (2170); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7441870
• MDR Text Key: 105881944
• Report Number: 3012307300-2018-01188
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315047350
• UDI-Public: 15019315047350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 100/875/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1