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

Model Number	267014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Tourniquet broke and snapped back.No injury to patient.A second device with a different lot number also broke.Concern was potential harm to patient and employee.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC.; 25 heywood road; arden NC 28704
• MDR Report Key: 7629011
• Report Number: 7629011
• Device Sequence Number: 14047341
• Product Code: LHI
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999(17)201231(10)245264
• 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): 06/18/2018
• Report Date (Section F): 06/18/2018

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 Expiration Date: 12/31/2020
• Device Model Number: 267014
• Device Catalogue Number: 267014
• Device Lot Number: 245264
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2018
• 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: 06/18/2018