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

Lot Number 18GBE827

Device Problem Crack (1135)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Medline iv start kit cracked shortly after placement.Extension set tubing cracked at the end of the line.Lot number (10) 18gbe827.

• Brand Name: I.V. START KIT
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8267021
• MDR Text Key: 133754874
• Report Number: 8267021
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 18GBE827
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1