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

Catalog Number 100/518/080

Device Problem Inflation Problem (1310)

Patient Problem Dyspnea (1816)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that the cuff of the tracheostomy tube "de-ballooned" on immediate trial.It was stated that the issue occurred during testing, however, it was also stated the patient had difficulty breathing.No permanent injury was reported.

Manufacturer Narrative

One smiths medical portex tt adult tracheostomy (trach) tube was returned for analysis in used condition.No discrepancies were found upon visual examination.A syringe was used to inflate the cuff and submerged under water to verify for leaks; finding no discrepancies.Relevant document were reviewed and deemed adequate.An audit of the production floor was conducted and operations were reviewed: training records, inflation line assembly operation, and cuff assembly operation.No discrepancies were found following review of operations.The inflation test was audited during thirty two (32) units revealing no deflated cuffs.Based on the evidence, no root cause has been determined since the complaint was not confirmed.

• Brand Name: PORTEX® BLUE LINE® CLASSIC TRACHEOSTOMY TUBES
• 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 INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7481191
• MDR Text Key: 107161294
• Report Number: 3012307300-2018-01260
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

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: No Information
• Device Expiration Date: 11/25/2020
• Device Catalogue Number: 100/518/080
• Device Lot Number: 3104408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1