MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number 100/870/080

Device Problem Crack (1135)

Patient Problem Airway Obstruction (1699)

Event Type  Injury  

Event Description

Information received a smiths medical tracheostomy pvc - portex tubes blue line ultra (blu) tip of the sub glottic port has cracked.Patient required immediate tracheostomy change out.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11711947
• MDR Text Key: 246952635
• Report Number: 3012307300-2021-03380
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (y/n): N
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 4039627
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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