MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/060

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: month and year of event have been provided, day is unknown.Lot number, expiration date and manufacture date are unknown, no information has been provided to date.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 Description

It was reported that after 10 days in use for the patient, the pilot balloon had detached from the inflation tube connection.When attempting to measure cuff pressure, the pilot balloon detached from the inflation tube connection, even though no significant force was applied.Adverse effects are unknown.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, it was noticed that inflation line was detached from pilot balloon.The complaint was confirmed.A root cause for the condition has not been determined.A device history record (dhr) review could not be performed as the lot number was unknown.This issue was escalated with further actions being taken accordingly.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY
• 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: 18048608
• MDR Text Key: 327084248
• Report Number: 3012307300-2023-10122
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076127
• UDI-Public: 15019517076127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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: 101/860/060
• Device Catalogue Number: 101/860/060CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1