ARROW PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IN THE COMPUTED TOMOGRAPHY (CT) DEPARTMENT WITH ALL EXTENSION LUMENS OF THE PICC CAPPED PRIOR TO THE PROCEDURE. AT THE START OF THE SCAN, THE CT TECHNICIAN FLUSHED AND UTILIZED THE PINK LUMEN, WHICH WAS CONFIRMED TO BE FUNCTIONING PROPERLY AT THAT TIME. DURING THE CT SCAN, THE PATIENT REPORTED HEARING A "POP" FROM THE PICC LINE. UPON INSPECTION BY CT STAFF, THE DRESSING WAS OBSERVED TO BE SATURATED WITH BLOOD AND ACTIVELY DRIPPING. THE PINK LUMEN CONTINUED TO HAVE BLOOD RETURN; HOWEVER, FLUSHING RESULTED IN INCREASED FLUID DRAINAGE FROM THE SITE. A FLOOR CONTROL TECHNICIAN ASSESSED THE PATIENT IN THE CT DEPARTMENT AND REPORTED SIMILAR FINDINGS. IT WAS FURTHER NOTED THAT FLUSHING OF THE BLUE AND WHITE LUMENS DID NOT RESULT IN ADDITIONAL FLUID DRAINAGE, AND BOTH LUMENS MAINTAINED BLOOD RETURN. THE PICC WAS SUBSEQUENTLY REMOVED. UPON REMOVAL, A HOLE/TEAR WAS CLEARLY OBSERVED IN THE CATHETER BETWEEN THE WINGED HUB AND THE 0 CM MARK. ADDITIONAL INFORMATION INDICATED THAT THE TRIPLE LUMEN ARROW PICC HAD BEEN INSERTED ON (B)(6) 2026 AND HAD FUNCTIONED WITHOUT REPORTED ISSUES PRIOR TO THIS EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.