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

Catalog Number 100/860/080

Device Problems Air Leak (1008); Material Deformation (2976); Torn Material (3024)

Patient Problem Apnea (1720)

Event Date 04/19/2017

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 invesitgation site.

Event Description

It was reported that a portex® cuffed blue line ultra® suctionaid tracheostomy tube had a leak.During a regular patrol, the nurse found that the patient's thorax did not move and went into respiratory arrest.A section was attempted, but the suction catheter couldn't be inserted due to the amount of secretion.The tracheostomy tube was then replaced.When checking the tracheostomy tube, it was noted that the cuff experienced an air leak.It was also observed that the cuff was largely torn and there was a "deformation" (one-sided inflation).The device was tested according to the instructions for use prior to insertion.The patient was resuscitated after the respiratory arrest.No permanent injury was reported, and the outcome of the event was reported to be full resolution.

Manufacturer Narrative

One device was returned for evaluation in used condition and without its original packaging.Visual inspection of the device found that there was a hole in the cuff.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A review of the inflation test was performed on 32 devices and found no deflated cuffs.Based on the evidence, the complaint was observed and a root cause was unable to be determined.

• Brand Name: PORTEX® CUFFED 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: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6567151
• MDR Text Key: 75160494
• Report Number: 3012307300-2017-01025
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Catalogue Number: 100/860/080
• Device Lot Number: 3252020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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): Life Threatening; Required Intervention