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

Catalog Number 100/815/080

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/12/2016

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 during a home visit for a planned "3/52" (weeks) tracheostomy tube change by a community registered nurse (rn), a portex blue line ultra cuffed tracheostomy tube cuff was deflated using a syringe and 1ml of clear fluid was withdrawn from the cuff via the pilot line.It was observed upon arrival that there was no condensation and no fluid in the tracheostomy tube pilot balloon and no fluid in the pilot line.It was confirmed prior to changing the tube that it maintained the prescribed pressure of "30" (cm h2o) and the ventilator was working well.The tracheostomy tube was changed "every 3/52" (weeks) due to cuff leaks that resulted in ventilator malfunction and alarms activating overnight.No patient injury was reported.

• Brand Name: PORTEX® BLUE LINE ULTRA® CUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5970053
• MDR Text Key: 55436870
• Report Number: 2183502-2016-02065
• 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: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 100/815/080
• Device Lot Number: 2882383
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1