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

Catalog Number 100/860/075

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Apnea (1720)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after starting to use a tracheostomy tube with a ventilator, the patient's breathing condition gradually worsened and one week later it prevented him from breathing.The customer attempted to change the patient's posture, to intervene, and apply tension to maintain proper orientation of the tube, but the patients condition did not improve and a tracheostomy tube changeout was required.Following the tube change the patient's breathing condition stabilized.It was further reported that the patient has since recovered.

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 cuff inflated for 24 hours; no leakage occurred during the extended testing.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.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 ULTRA® SUCTIONAID® TRACHEOSTOMY TUBE
• 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: 7615519
• MDR Text Key: 111542381
• Report Number: 3012307300-2018-02418
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/860/075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention