MAUDE Adverse Event Report: COVIDIEN SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 6CN75H

Device Problems Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Patient is trached.With a recalled possible defective trach in airway.Certain adult sized shiley trachs have been recalled.It has been confirmed that this patient has one of the recalled trachs in her airway.Shiley substitute trachs (not on recall) are ready at bedside.Respiratory care team has consulted with picu md team, about the recall trach the patient currently has.First reported to md team in evening.According to charge rcp's (respiratory care practitioner) over the weekend, ent has been contacted and wish to wait till monday to change the trach.Due to possibility of a bleeding event from the patient, due to their current condition.Recommend: patient safety is of paramount importance.All md groups involved in care agree to wait on changing trach, due to patient's condition.Recommend changing trach when all agree is safe for patient.No noted patient harm or device failure from recalled trach.Trach changed and transitioned to trilogy ventilator.All remaining recalled items removed from service as permitted by medical teams.Trach involved: 7.5 adult cuffed shiley (id 7.5, od 10.8, length 74mm; 6cn75h).

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16875786
• MDR Text Key: 314629490
• Report Number: 16875786
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6CN75H
• Device Catalogue Number: 6CN75H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2023
• Date Report to Manufacturer: 05/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Sex: Female