MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX UNIPERC PERCUTANEOUS DILATION KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/070
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tracheostomy tube is not being held securely by the flange.Despite being locked, the tube slipped through and advanced 3.5cm into the patient's airway.Also noted that the connector at the end of the tracheostomy tube (to connect to circuit) is loose and disconnects easily.No injury reported.Patient involvement.Patient information is not available.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Other, other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device sample was received in used condition without the original packaging.Per visual inspection it was noticed that blue locking lever is incorrectly assembled with flange body (it cannot lock).Disassembled locking lever and correctly assembled it back.We can confirm that after assembly locking mechanism works well.The complaint was confirmed.The root cause was identified to be in design of adjustable flange which allows to unscrew blue locking lever.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Similar customer complaints were received in the past therefore this issue was escalated to complaint trend process.The occurrence of this issue is being monitored.

• Brand Name: PORTEX UNIPERC PERCUTANEOUS DILATION KIT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18047885
• Report Number: 3012307300-2023-10112
• Device Sequence Number: 8076999
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: (01)15019315060434(11)210920(17)260831(10)4149639
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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: 08/31/2026
• Device Model Number: 100/897/070
• Device Catalogue Number: 100/897/070CZ
• Device Lot Number: 4149639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 12/01/2023; Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 03/06/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown