MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLU-SELECT SUCTIONAID TRACHEOSTOMY TUBE, CUFFED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 101/860/070CZ

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: month and year of event have been provided, but day is unknown.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.Investigation summary: one used decontaminated sample was returned for investigation.Under visual inspection it was found that the inflation line was detached from the pilot balloon, confirming the customer's indicated failure.This issue was escalated to capa-000905 and the occurrence is being monitored via tnd-00138.A device history record could not be completed as no lot number was received.

Event Description

It was reported that the pilot balloon had come loose from the inflation line joint.There was patient involvement and no patient harm adverse event reported.

• Brand Name: PORTEX BLU-SELECT SUCTIONAID TRACHEOSTOMY TUBE, CUFFED
• Type of Device: 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18897690
• MDR Text Key: 337665114
• Report Number: 3011237704-2024-00059
• Device Sequence Number: 1
• Product Code: BTO
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 101/860/070CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1