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

Catalog Number 100/515/075

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that when drawing air with a syringe during use of the tracheostomy tube, some fluid "flew" from the pilot balloon.No injury was reported.

Manufacturer Narrative

One used sample was returned for evaluation.The returned device was given functional testing: a syringe was attached and the cuff was filled with air as per device instructions.The cuff was found to fully inflate with no leakage detected.The device was left with the cuff inflated for 24 hours; no leakage was observed during that time.The reported issue could not be confirmed.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.This review included the following procedures: basic assembly and cuff inflation testing.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.The root cause could not be established; the returned device was found to meet with specifications.

• Brand Name: PORTEX® BLUE LINE CLASSIC®
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; 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: 7660554
• MDR Text Key: 113149503
• Report Number: 3012307300-2018-02527
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/515/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability