MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number DYNDTN1603

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2023

Event Type  malfunction  

Event Description

Case #1: lipids noted to be leaking from cracked iv tubing and on floor of iv pole.Infant did not receive all of lipid infusion.Case #2: when assessing patient at the bedside, registered nurse (rn) noticed that the lipids were leaking down the tubing outside of the patient bed.Upon further investigation the lipid tubing would not tighten onto the tip of the syringe appropriately.Night rn changed lipid tubing early on due to leaking because they thought it was the tubing but it appears to be the tip of the syringe.Pharmacy was notified and neonatal nurse practitioner (nnp) advised rn to turn lipids off.Case #3: night shift registered nurse changed lipid tubing due to blood backing up in picc line and noted leaking.Dayshift registered nurse assessed infant and noticed lipids were leaking down the tubing right where they are connected to the syringe on the iv pump.Pharmacy and nnp were contacted.New lipids to be hung with fresh tubing and old lipids along with tubing given to pharmacy.Manufacturer response for 60" iv extension set, product # dyndtn1603 (medline) (per site reporter).Unknown.

• Brand Name: MEDLINE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 16731665
• MDR Text Key: 313223725
• Report Number: 16731665
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/29/2023,03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNDTN1603
• Device Catalogue Number: DYNDTN1603
• Device Lot Number: (10)0332210A194
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1