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

Model Number 100/199/070

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information received a smiths medical intubation|portex endotracheal tubes had foreign unknown material on the tubes.Multiple reports of white powdery specks and spots found on the cuffs of these tubes.Reported substance would rub off when wiped.No patient injury reported.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; manukau city centre; minneapolis, MN 55442
• MDR Report Key: 12197445
• MDR Text Key: 262481506
• Report Number: 3012307300-2021-07399
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 15019315022326
• UDI-Public: 15019315022326
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K790312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/199/070
• Device Catalogue Number: 100/199/070
• Device Lot Number: 4029080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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