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

Catalog Number 100/515/070

Device Problem Air Leak (1008)

Patient Problem Hyperventilation (1910)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.

Event Description

It was reported that a portex® blue line ultra® suctionaid tracheostomy tube had an air leak during use on a patient.It was unknown how long the tube was in use and if the tube was checked prior to use.The patient experienced tachypnea due to the incident.An emergent tracheostomy tube change was conducted to address the issue.No permanent injury was reported.The event was considered resolved.

Manufacturer Narrative

Upon receipt of the returned product specimen, it was visually examined.One tracheostomy tube was returned for evaluation.Visual examination revealed a hole in the cuff.The complaint was confirmed.These devices are 100 percent in-house inflation tested prior to release for distribution.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6390968
• MDR Text Key: 69483351
• Report Number: 3012307300-2017-00647
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention