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

Catalog Number 100/150/080

Device Problems No Pressure (2994); Unintended Movement (3026)

Patient Problem Hypovolemic Shock (1917)

Event Date 07/15/2019

Event Type  Injury  

Event Description

Information was received indicating that follow placement of a smiths medical portex® endotracheal tube the manometer read zero pressure; with the cuff seeming over-inflated.The cuff was checked again with the same reading leading to a third test being performed with another manometer indicating the same zero pressure reading.Hemodynamic instability was reported with the tube slipping 2 cm.Re-securement and the re-positioning of the tube was done.However, the decision was made to reintubate the patient and hemodynamic stabilization was required.There were no further reported adverse effects.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9226705
• MDR Text Key: 164343359
• Report Number: 3012307300-2019-05395
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Catalogue Number: 100/150/080
• Device Lot Number: 19022580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2019
• 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