inforMED
MalfunctionFOS

ARGYLE

Received Mar 19, 2025 · Event occurred Mar 2, 2025

Report 21641964 · MDR key 21641964

Device

Generic name

Catheter, Umbilical Artery

Manufacturer

Cardinal Health

Model number

8888160556

Catalog number

8888160556

Lot number

240440070

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

UMBILICAL VEIN CATHETER (UVC) WAS PLACED AS WE WERE UNABLE TO OBTAIN PERIPHERAL INTRAVENOUS (PIV) ACCESS. UVC WAS PLACED AND INFANT TOLERATED PROCEDURE WELL. WHEN THIS REGISTERED NURSE (RN) WENT TO HOOK UP FLUIDS TO THE UVC PRIMARY HUB, THE IV TUBING WOULD CONNECT, BUT NOT SCREW ON. IT JUST KEPT TURNING AND NOT SCREW ON TIGHTLY. THE RN TRIED TO SCREW THE IV FLUIDS ON TO THE SECONDARY LUMEN HUB AND THE IV FLUIDS WOULD ALSO NOT SCREW ON PROPERLY BUT WERE TIGHTER THAN THE PRIMARY LUMEN HUB. NEONATAL NURSE PRACTITIONER (NNP) CALLED TO THE BEDSIDE AND THE SITUATION WAS EXPLAINED. NNP STUDENT WHO PLACED THE UVC STATED THAT HE DIDN'T NOTICE ANY DIFFICULTY WHEN SCREWING ON A SYRINGE TO DRAW LABS AND VERIFY UVC PLACEMENT. UPON FURTHER INVESTIGATION, IT LOOKED LIKE THERE WERE "RIDGES" ON THE PRIMARY HUB THAT PREVENTED IV FLUIDS FROM BEING TIGHTENED PROPERLY. IT WAS DECIDED THAT WE WOULD NOT USE THE PRIMARY HUB, AND IT WAS TAPED OFF, SO ALL OTHER STAFF KNEW NOT TO USE. AS FOR THE SECONDARY, A CLAVE WAS PLACED TO HELP MAKE THE CONNECTION TIGHTER, AND IV FLUIDS WERE BEING RAN THROUGH THE SECONDARY LUMEN. UVC MANUFACTURER WAS COVIDIEN AND THE LOT # WAS 240440070.