MAUDE Adverse Event Report: COVIDIEN LP SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 8PERC

Device Problems Disconnection (1171); Mechanical Problem (1384)

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

Event Date 11/02/2017

Event Type  malfunction  

Event Description

On [date redacted], the patient was intubated with a shiley #7.5mm in the emergency department to protect airway.Two weeks later, the patient was trached and a #8 shiley was inserted.The next day early a.M., the physician documented that there was no problem with the trach.Trach examined and looked ok.Indicated sutures can come out of trach in four days.Nurse and respiratory therapist noted the cannula of the #8 shiley was not attached to the flat disc part of the trach.It was out about 1/4 inch; trach cuff inflated.Doctor was made aware.At 0845, doctor noted that the trach flange appeared to be disconnected from the tube.Doctor could not fix the mechanical issue with the current tube making it more unstable.Later in the day, the doctor replaced the entire trach with a new #8 shiley percutaneous tracheostomy tube.The patient tolerated the procedure well.Facility would like manufacturer to contact writer regarding to discuss process for returning the trach to manufacturer for inspection.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7116487
• MDR Text Key: 94824400
• Report Number: 7116487
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8PERC
• Device Catalogue Number: 8PERC
• Device Lot Number: 16J0578JZX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2017
• Device Age: 16 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2017
• 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 Age: 26 YR
• Patient Weight: 52