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

Catalog Number 100/851/070

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a portex® blue line ultra® fenestrated inner cannula was found to have "fractured" between the fenestrations after seven days in use.The device had been cleaned with warm water.It was noted that "extra education was offered", but the correct procedures were being followed regarding cleaning.No injury was reported.See mfr: 3012307300-2017-01148.

Event Description

The staff observed the fenestration holes in the inner cannula before placing back into the tracheostomy tube.

Manufacturer Narrative

One used portex® blue line ultra® fenestrated inner cannula was received for investigation.A visual inspection was performed and the inner cannula was confirmed to be damaged in the middle.A review of the manufacturing process was conducted and no discrepancies were found.The most probable root causes for the damage was determined to be either: the product was damaged after it left the manufacturing facility, or the product was damaged during the manufacturing process and was not detected by product personnel.

• Brand Name: PORTEX® BLUE LINE ULTRA® FENESTRATED INNER CANNULA
• 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: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6602682
• MDR Text Key: 76402532
• Report Number: 3012307300-2017-01147
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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: Health Professional
• Device Catalogue Number: 100/851/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 07/28/2017; 02/22/2018
• Supplement Dates FDA Received: 08/18/2017; 03/16/2018
• 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: Reuse
• Patient Sequence Number: 1