MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE TRACHEOSTOMY TUBE, VOCALAID

Catalog Number 100/517/075

Device Problem Positioning Problem (3009)

Patient Problems Cyanosis (1798); Pneumothorax (2012); Respiratory Distress (2045); Extubate (2402)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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

User facility reported a patient underwent a tracheotomy, and the listed tracheostomy tube was put in place with the patient.It was reported that twenty-four hours later, a nurse was repositioning the patient when it was noticed that the device flange was out of position (2cm away from stoma).The reporter explained that the end of the tracheostomy tube was believed to have come in contact with the patient's trachea wall.According to the reporter, the patient was cyanosed, pale, aspirated, and going through respiratory arrest.The patient was reportedly given chest compressions, was resuscitated with a resuscitation bag, and had their tracheostomy tube replaced emergently.The reporter further explained that right pneumothorax occurred, and the patient's pleural space had to be drained.No permanent injury was reported.

• Brand Name: PORTEX BLUE LINE TRACHEOSTOMY TUBE, VOCALAID
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5612355
• MDR Text Key: 43800309
• Report Number: 2183502-2016-00854
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/517/075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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