MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC 306 IV START KIT; I.V, START KIT

Lot Number 256353

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

The tegaderm in the iv start kit was not usable.The disposable boarder that supports to tegaderm during application had not adhesive so was not stuck to the tegaderm making the tegaderm unusable.Surgery has seen a number of these kits with this problem.Fda safety report id# (b)(4).

• Brand Name: IV START KIT
• Type of Device: I.V, START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC 306; mechanicsville VA 23116
• MDR Report Key: 8758238
• MDR Text Key: 150142066
• Report Number: MW5087805
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Lot Number: 256353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1