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

Model Number	4UN65H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Insertion of a size 4 inner trach cannula - in metric it's listed as 6.5 mm on the packaging and this was interpreted as us size 6 inner trach cannula.Manufacturer response for disposable inner cannula, shiley (per site reporter).Manufacturer states they are aware of issue and are in process of changing package labeling.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8083891
• Report Number: 8083891
• Device Sequence Number: 1332196
• Product Code: JOH
• UDI-Device Identifier: 20884521176239
• UDI-Public: (01)20884521176239
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018
• Report Date (Section F): 11/09/2018

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
• Operator of Device: Health Professional
• Device Model Number: 4UN65H
• Device Catalogue Number: 4UN65H
• Device Lot Number: 18B0754JZX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 11/09/2018