MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/899/070
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a patient had a tracheostomy put in place approximately over three (3) and a half weeks ago counting from (b)(6) 2025.Due to the clip failing a new one was put in place.The clip held in place with no issues for a week and a half but then started to slip causing the tracheostomy to come out of place.The reporter stated they needed to change the tube and insert a new one.There was patient involvement, and no adverse harm reported.The second event is documented on emdr-73306.
Additional Manufacturer Narrative
H3: one used decontaminated sample was returned for investigation without its original packaging.Visual inspection was performed, and it was noticed that the blue locking lever was incorrectly assembled with flange body (it cannot lock).The locking lever was disassembled and was correctly assembled back.The locking mechanism was confirmed to work well after the assembly.Similar customer complaints related to uniperc flange locking mechanism were received in the past therefore this issue was solved via capa 19mczh102.A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22686514
• Report Number: 3012307300-2025-09159
• Device Sequence Number: 9663928
• Product Code: BTO
• UDI-Device Identifier: 15019315107221
• UDI-Public: (01)15019315107221
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Model Number: 100/899/070
• Device Catalogue Number: 100/899/070CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Weight: 100 KG