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

Model Number 267014

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

Patient Problem No Information (3190)

Event Date 10/30/2017

Event Type  malfunction  

Event 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 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
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood rd.; arden NC 28704
• MDR Report Key: 7058618
• MDR Text Key: 92924724
• Report Number: 7058618
• Device Sequence Number: 1
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999
• 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,Followup
• Report Date: 10/31/2017,11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/22/2020
• Device Model Number: 267014
• Device Lot Number: 237861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1