MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.-MEXICALI (MCX) IV START KIT WITH PI EXTENSION SET; I.V. START KIT

Model Number DYNDV2395

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Nurse was doing an iv start with intent for blood draw.Connected extension tubing from iv start kit with vacutainer at end to iv catheter.Blood was leaking from the extension catheter, regardless of tightening the connection.Changing the extension tubing solved the leakage issue.

• Brand Name: IV START KIT WITH PI EXTENSION SET
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.-MEXICALI (MCX); three lakes drive; northfield IL 60093
• MDR Report Key: 11816812
• MDR Text Key: 250419370
• Report Number: 11816812
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDV2395
• Device Catalogue Number: DYNDV2395
• Device Lot Number: 20200407090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA