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

Catalog Number 100/800/080

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Pneumothorax (2012); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Ulcer (2274)

Event Date 07/06/2017

Event Type  Death  

Manufacturer Narrative

See mfr: 3012307300-2017-01996.Report source: (b)(6).Two devices were returned for evaluation in used condition and without their original packaging.Visual inspection found one of the samples had a hole in the cuff and the other sample had a herniation.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 or anomalies.A sample of 32 devices underwent leak testing and did not identify any deflated or deformed cuffs.A review of the instructions for use was performed.Based on the evidence, a root cause was unable to be determined.

Event Description

It was reported that the patient expired after a malfunction of a portex® cuffed blue line ultra® tracheostomy tube.It was reported that the patient sustained a tracheal injury by "explosion" of the cuff.While attempting to perform a cannula replacement, "bulging" was observed and it was necessary to change the tracheostomy tube twice.It was observed that the patient experienced a tracheal lesion due to the cuff, followed by bilateral pneumothorax, hemodynamic instability, and cpr.Patient required cpr for 40 minutes and was moved to electrical cardioversion and prescribed amiodarone when patient went into ventricular fibrilation and tachycardia.Cpr was restarted and patient passed away 7 minutes later.

• Brand Name: PORTEX® CUFFED BLUE LINE ULTRA® 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 INTERNATIONAL LTD; 1500 eureka park; lower pemberton; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7346717
• MDR Text Key: 102702946
• Report Number: 3012307300-2018-00666
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Catalogue Number: 100/800/080
• Device Lot Number: 3178852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 74