MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. MEDICAL ACTION INDUSTRIES; TRACHEOTOMY CARE KIT

Model Number	75378
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When new trach care tray was opened, there is brown substance on the contents of the package.The contents appear dirty.This was not utilized on a patient.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Common Device Name: TRACHEOTOMY CARE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood rd.; arden NC 28704
• MDR Report Key: 7439477
• Report Number: 7439477
• Device Sequence Number: 13830645
• Product Code: NXA
• UDI-Device Identifier: 10809160022221
• UDI-Public: (01)10809160022221
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018
• Report Date (Section F): 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 02/23/2019
• Device Model Number: 75378
• Device Catalogue Number: 75378
• Device Lot Number: 239123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/06/2018