* 267014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-09 for * 267014 manufactured by Medical Action Industries.

Event Text Entries

[4110766] While using the chloraprep applicator from the iv start kit to clean an intended iv site, the chloraprep sponge caused abrasions to patient's arm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3519913
• MDR Report Key: 3519913
• Date Received: 2013-12-09
• Date of Report: 2013-12-09
• Date of Event: 2013-12-03
• Report Date: 2013-12-09
• Date Reported to FDA: 2013-12-09
• Date Reported to Mfgr: 2013-12-16
• Date Added to Maude: 2013-12-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: KIT, IV START
• Product Code: LRS
• Date Received: 2013-12-09
• Model Number: *
• Catalog Number: 267014
• Lot Number: 176017
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL ACTION INDUSTRIES
• Manufacturer Address: 25 HEYWOOD ROAD ARDEN NC 28704 US 28704

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-09