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

Model Number 100/897/070

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 10/09/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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: jim vegel
• MDR Report Key: 18047885
• MDR Text Key: 327075302
• Report Number: 3012307300-2023-10112
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: 15019315060434
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1