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

Catalog Number 100/860/075

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that during the use of this endotracheal tube a ventilation failure alarm sounded.The patient's spo2 level dropped to around 80, and the patient had cyanosis.A doctor was called in and the patient required manual resuscitation with a bag valve mask.However, the doctor felt major resistance and was unable to feed air into the patient, which temporarily suffocated the patient.This tracheostomy tube was removed and replaced and the patient was able to recover.No additional adverse patient effects were reported.

• Brand Name: PORTEX® CUFFED BLUE LINE ULTRA® SUCTIONAID
• 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: 7642634
• MDR Text Key: 112491195
• Report Number: 3012307300-2018-02576
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/860/075
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention