inforMED
MalfunctionOKE

PORT INTRODUCER KIT

Received Feb 6, 2018 · Event occurred Nov 24, 2017

Report 7244264 · MDR key 7244264

Device

Generic name

Port Introducer Kit

Manufacturer

Cardinal Health

Product problems

  • Detachment Of Device Component
  • Fluid/Blood Leak
  • Chemical Spillage

Patient

Not reported

  • Chemical Exposure
  • Chemical Exposure

Narrative

Description of Event or Problem

PATIENT IN FOR CADD DISCONNECT, STATING AT 4 A.M. WHEN HE GOT UP TO USE THE BR HE FELT LIKE HIS SHIRT WAS WET AND NOTICED THAT THE TUBING FOR PORT ACCESS TO THE CHEMO BALL WAS BROKEN AND BLOOD WAS COMING OUT OF TUBING PROXIMAL TO PORT SITE. HE STATES THAT HE HAD TO CUT THE TUBING TO GET THE CLAMP TO STOP THE BLOOD FROM COMING OUT OF THE PORT. PATENT STATES THE BALL WAS FLAT AT THIS TIME AND A VERY SMALL AMOUNT OF CHEMO WAS SPILLED. PATIENT STATES THAT THEY USED THE SPILL KIT TO CLEAN UP THE SPILL. PATIENT STATES THAT HE WENT TO THE ER TO BE EVALUATED. THE ER LEFT THE PORT NEEDLE IN PLACE AND PATIENT CAME TO UNIT TO BE DE ACCESSED. PORT NEEDLE TAKEN OUT DUE TO NO PLACE FOR IT TO BE ACCESSED AND FLUSHED. PATIENT THEN RE ACCESSED AND FLUSHED PER PROTOCOL WITH NO DIFFICULTIES. PATIENT INSTRUCTED TO BAG UP HIS CLOTHING FROM THE SPILL UNTIL RN COULD FURTHER INVESTIGATE WHAT APPROPRIATE ACTION TO TAKE WITH THE CLOTHING. MD MADE AWARE, WITH NO NEW ORDERS AT THIS TIME.