InjuryGBW
MEDICOMP PORT CT IMPLANT (SILICONE) 9.6 FR
Received Jan 19, 2012 · Event occurred Jan 3, 2012
Report MW5023936 · MDR key 2428361
Device
Product problems
- Detachment Of Device Component
- Material Rupture
Patient
48 YR
- Pain
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
ON (B)(6) 2012, (B)(6) YEAR OLD FEMALE RECEIVING CHEMOTHERAPY VIA MEDIPORT. STAFF ATTEMPTED TO FLUSH MEDIPORT BEFORE CHEMO ADMINISTRATION. PT EXPERIENCED PAIN AT SITE AND FLUID SEEN AROUND HUB AT INSERTION SITE. DYE STUDY REVEALED MEDIPORT HAD SEPARATED/RUPTURED INTERNALLY. VASCULAR SURGEON ABLE TO REMOVE TIP OF CATHETER FROM PT'S PULMONARY ARTERY WAS VASCULAR CATHETERIZATION.