SPECIAL BOLUS NEEDLE HAI STRAIGHT LENGTH 1 3/8" (3.5CM)

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY COMMUNICATED WITH THE CLINIC TO OBTAIN ADDITIONAL INFORMATION. THE CLINIC HAS NOT RELEASED ANY INFORMATION DUE TO HIPAA CONCERNS. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS INCONCLUSIVE.

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, AN INTERVENTIONAL RADIOLOGY NURSE MENTIONED THAT THE CLAMP ON THE SPECIAL BOLUS NEEDLE (SBN) THAT WAS USED DURING A HAPS SCAN DIDN'T CLAMP THE TUBE AND CAUSED BLOOD TO FLOW INTO THE SBN TUBE. THE NURSE STATED THAT THE CLAMP WORKED, BUT THE TUBE WAS STILL COMPLETELY OPEN, AND IT WAS JUST GOING AROUND THE CLAMP. AFTER FLUSHING THE SBN WITH 10ML OF INJECTABLE SALINE HE WAS SUCCESSFUL AT CLAMPING THE SBN WITHOUT GETTING ANY BACKFLOW.