MAUDE Adverse Event Report: COVIDIEN LP (MEDTRONIC) COVIDIEN - SHILEY; TUBE, TRACHEOSTOMY

Model Number PERC8

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

During bedside bronchoscopy, percutaneous tracheostomy tube tip became bent and could have caused harm to the patient.Procedure continued with another trach tube.This is the second time i have witnessed this exact problem with percutaneous tracheostomy tubes.Previous issue was with a different doctor.Per site reporter: no response from manufacturer yet.

• Brand Name: COVIDIEN - SHILEY
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): COVIDIEN LP (MEDTRONIC); 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7495859
• MDR Text Key: 107686210
• Report Number: 7495859
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

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
• Device Operator: Physician
• Device Expiration Date: 08/22/2022
• Device Model Number: PERC8
• Device Catalogue Number: 8PERC
• Device Lot Number: 17H0686JZX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR