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

Model Number	267014
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When starting an iv on this patient, scrubbing with the sponge, unknown if there was a piece of plastic or something on the sponge but it made scrape marks on his arm.

• 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: 11228740
• Report Number: 11228740
• Device Sequence Number: 11744275
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999(17)230731(10)278822
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/08/2021
• Report Date (Section F): 01/08/2021

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: 267014
• Device Lot Number: 278822
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 109
• Date Report Sent to FDA: 01/08/2021