MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. IV START KIT; I.V. START KIT

Lot Number 2019102390

Device Problem Protective Measures Problem (3015)

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

Event Date 02/05/2020

Event Type  malfunction  

Event Description

Medline iv start kit with flush without luer kit came with syringes that do not have a safety on them.The product number is dynj58454 and the lot number is 2019102390.Manufacturer response for iv start kit, (brand not provided) (per site reporter).Working with manufacturer to identify cause of improper syringe in kit.

• Brand Name: IV START KIT
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9935402
• MDR Text Key: 186817825
• Report Number: 9935402
• Device Sequence Number: 1
• Product Code: LRS
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2019102390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2020
• Event Location: Other
• Date Report to Manufacturer: 04/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1