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

Model Number	101/800/060CZ
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes bluselect malfunctioned.The customer started using the product from regular replacement and it worked for a while.However, after that, the patient's mother noticed the inflation line for the pilot balloon was torn.So the customer changed the product another new one.No patient injury.
Additional Manufacturer Narrative
H10: device evaluation: one used decontaminated sample 10009142-001 blu deht tracheostomy tube 6.0mm s/assy was received in plastic bag without its original packaging (see photo of sample).Under visual inspection we observed following damages: inflation line was cut by some sharp tool (clear cut); inflation line is not full length; cut on surface of inflation line; inflation line removed from pilot balloon; conditions of returned sample indicates poor user handling.Manufacturing related fault is highly improbable in this case.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.The cause of the reported problem was traced to the user manipulation of the device during placement.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 12215196
• Report Number: 3012307300-2021-07521
• Device Sequence Number: 19163350
• Product Code: BTO
• UDI-Device Identifier: 15019517076066
• UDI-Public: 15019517076066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2024
• Device Model Number: 101/800/060CZ
• Device Catalogue Number: 101/800/060CZ
• Device Lot Number: 3895097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown