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

Catalog Number 100/860/070

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problems Distress (2329); No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

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 the "blown up" cuff of a portex® blue line ultra® suction aid® tracheostomy tube had become detached from the tubing.The incident occurred at the patient's home.The patient's parents noticed the fault when they were changing the patient's shirt.An emergency tracheostomy tube change was required as the cuff deflated and the child became "distressed".No permanent injury was reported.

Manufacturer Narrative

One portex® blue line ultra® suctionaid® tracheostomy tube was returned within a plastic bag in a used condition without the original packaging.Visual inspection found that the pilot balloon was detached from the pvc tube.No other defects were observed, inflation line was not found to be stretched by excessive force.Unusual solvent spots were noted upon magnification of the device which indicated that the pilot balloon and inflation line were not connected together in time; solvent dried before connection of two parts.A review of the device history records shows there were no observations recorded during manufacturing of this lot of product.The complaints trend review identified no previous confirmed complaints in relation with this issue.Based on the evidence, the complaint is confirmed.The pilot balloon detached from the inflation line.There was no trend identified, current production was reviewed and a manufacturing notification was sent.

• 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 MEDICAL CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6678391
• MDR Text Key: 78726157
• Report Number: 3012307300-2017-01394
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 09/15/2021
• Device Catalogue Number: 100/860/070
• Device Lot Number: 3282161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR