ARGYLE
Received Sep 7, 2022 · Event occurred Aug 19, 2022
Report 15369818 · MDR key 15369818
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160341Catalog 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.