MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. MEDICAL ACTION INDUSTRIES; I.V. START KIT

Model Number	267014
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Ed staff stocking iv trays with medical action iv start kits ref (b)(4) lot 237861 and at least (7) sealed packages present in case container without any contents present(tourniquet, tape, chloraprep frepp, gauze, tegaderm, or iv change label).
Event or Problem Description
Ed staff stocking iv trays with medical action iv start kits ref 267014 lot 237861 and at least (7) sealed packages present in case container without any contents present(tourniquet, tape, chloraprep frepp, gauze, tegaderm, or iv change label).

• Brand Name: MEDICAL ACTION INDUSTRIES
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood rd.; arden NC 28704
• MDR Report Key: 7058618
• Report Number: 7058618
• Device Sequence Number: 1004595
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999
• 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,Followup
• Report Date (Section B): 11/16/2017
• Report Date (Section F): 10/31/2017

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: No Information
• Device Expiration Date: 05/22/2020
• Device Model Number: 267014
• Device Lot Number: 237861
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: 10/31/2017