MEDICAL ACTION 267014 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-17 for MEDICAL ACTION 267014 * manufactured by Medical Action Industries, Inc..

Event Text Entries

[3446829] As the nurse was applying a tourniquet to start an iv, she stretched the tourniquet to place and secure on the arm. It snapped in two causing a welt on her finger. Staff shared that they have had multiple occurrences of this same problem and found that the same iv start kit has one tourniquet but that it may originate from different countries. The one that originates in "my" is thinner, brittle and snaps apart easily. Nurses have a concern for the potential to injure a patient's fragile skin when it snaps apart. What was the original intended procedure? Iv access. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3177074
MDR Report Key	3177074
Date Received	2013-06-17
Date of Report	2013-06-17
Date of Event	2013-06-03
Report Date	2013-06-17
Date Reported to FDA	2013-06-17
Date Reported to Mfgr	2013-06-19
Date Added to Maude	2013-06-19
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	3
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	MEDICAL ACTION
Generic Name	KIT, IV START
Product Code	LRS
Date Received	2013-06-17
Model Number	267014
Catalog Number	*
Lot Number	163473
ID Number	*
Operator	NURSE
Device Availability	Y
Device Age	*
Device Sequence No	1
Device Event Key	0
Manufacturer	MEDICAL ACTION INDUSTRIES, INC.
Manufacturer Address	25 HEYWOOD RD ARDEN NC 28704 US 28704

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-17