inforMED
MalfunctionFOS

ARGYLE

Received Sep 7, 2022 · Event occurred Aug 19, 2022

Report 15369818 · MDR key 15369818

Device

Generic name

Catheter, Umbilical Artery

Model number

8888160341

Catalog number

8888160341

Lot number

1803800115

Product problems

  • Leak/Splash
  • Material Puncture/Hole
  • Malposition of Device

Patient

1 DA · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

CERTIFIED REGISTERED NURSE PRACTITIONER (CRNP) AND REGISTERED NURSE (RN) AT BEDSIDE FOR UMBILICAL VENOUS CATHETER (UVC) LINE INSERTION. LINE INSERTION COMPLETED AND X-RAY COMPLETED. IMAGING SHOWED MALPOSITIONED UVC WHICH NOTED TIP OF THE CATHETER TO THE RIGHT MIDLINE LIKELY WITHIN THE PORTAL VEIN. TWO RNS COMPLETED STERILE LINE PREP INCLUDING PRBCS. WHEN PRIMARY RN WENT TO CONNECT STERILE LINES TO THE UVC CATHETER, RN NOTICED BLOOD FLOWING BACK INTO THE UVC LINE AND LEAKING ON TO STERILE PREP FIELD. THE BLOOD WAS NOT BACKING UP THROUGH THE BLUE MICROCLAVE BUT WAS DRIPPING OUT OF PART OF THE UVC CATHETER. UPON INVESTIGATION, THE UVC APPEARED TO HAVE A HOLE IN THE CATHETER. CRNP CALLED TO BEDSIDE. UVC REMOVED AND NEW UVC PLACED. FAULTY UVC CATHETER PLACED IN BAG AND SAVED FOR FURTHER INVESTIGATION OF FAULTY PRODUCT.