VASCU-PICC

Additional Manufacturer Narrative

OUR INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

NEWLY PLACED PICC ON PATIENT (PLACED SAME DAY AT 1200). STATED CONCERN FOR BLEEDING AND SUSPECTED SALINE FLUSHES LEAKING. VAST ARRIVED TO ASSESS; PICC DRESSING SATURATED IN BLOOD, PATIENT DIAPER BLOODY FROM DRESSING BLEEDING AS WELL AS BLOODY BLANKET INFANT WAS WRAPPED IN. DRESSING REMOVED AND NO ACTIVE BLEEDING NOTED. PICC FLUSHED THROUGH BOTH LUMENS; IMMEDIATE LEAKING OF SALINE NOTED NEAR PICC INSERTION SITE. GAUZE AND OCCLUSIVE DRESSING APPLIED. VAST NOTIFIED PROVIDER FIRST CONTACT AND RECOMMENDED INTERVENTIONAL RADIOLOGY ASSESS LINE FOR MALFUNCTION PROMPTLY. IR DETERMINED LINE NEEDED REPLACEMENT.