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

Model Number 267014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 12/30/2020

Event Type  malfunction  

Event 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
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood road; arden NC 28704
• MDR Report Key: 11228740
• MDR Text Key: 228621759
• Report Number: 11228740
• Device Sequence Number: 1
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999(17)230731(10)278822
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 267014
• Device Lot Number: 278822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24090 DA
• Patient Weight: 109