inforMED
MalfunctionFPB

BAXTER -NON-DEHP THREE LEAD CATHETER EXTENSION SET

Received Dec 20, 2018 · Event occurred Nov 30, 2018

Report 8183985 · MDR key 8183985

Device

Generic name

Filter, Infusion Line

Model number

2N3342

Catalog number

2N3342

Lot number

(10) DR 18106024

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING THE INFUSION OF TPN PRODUCT IN THE NICU IT WAS NOTICED THE TUBING WAS LEAKING ON THE THIRD DAY. THE LEAKING WAS NOT IN THE CONNECTIVE PART OF THE TUBING. THE TUBING WAS DUE TO BE CHANGED THAT DAY. THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO OTHER MEDICAL FOLLOW-UP NECESSARY.