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

Catalog Number 100/515/080

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that the user found a cuff leak during use of the trachesotomy tube.No injury was reported.

Manufacturer Narrative

The reporter noted the patient required medical treatment and a tracheostomy (trach) change out due to the event.Therefore, the report is considered a serious injury instead of a malfunction.Device evaluation: one portex suctionaid sample was received in used condition without its original packaging.Immediate visual inspection noted a leak in the cuff of the sample.A leak and inflation test was completed and a leak was detected.The cuff assembly operation and inflation line assembly were reviewed to ensure operators were properly performed and that devices are manufactured correctly with no discrepancies.Samples were audited during thirty two (32) units finding no issues and no deflated cuffs.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and investigation, the complaint was confirmed.The problem source was stated to be unknown.

• Brand Name: PORTEX® BLUE LINE CLASSIC® 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
• MDR Report Key: 7643448
• MDR Text Key: 112556436
• Report Number: 3012307300-2018-02386
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 06/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention