MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/870/075

Device Problem Partial Blockage (1065)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the device was in use with patient.Reporter stated that during use the patient's airway was blocked with sputum.The patient was transferred to another hospital (b)(6) on an emergency basis.Additional information on the patient has been requested but not received at this time.No permanent adverse effects to patient reported.

• Brand Name: PORTEX BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7986339
• MDR Text Key: 124391757
• Report Number: 3012307300-2018-02026
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/870/075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention