FOLFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION (SUSPECTED FROM THE FILL PORT). THE DEVICE WAS FILLED WITH FLUOROURACIL AND SODIUM CHLORIDE. THE LEAK WAS OBSERVED PRIOR TO PATENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH WAS RECEIVED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT THERE WAS FLUID CONTAINED INSIDE THE BAG WHICH CONTAINED THE DEVICE WHICH SUGGESTED A LEAK HAD OCCURRED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED; HOWEVER, THE PHOTOGRAPH SHOWED A NON BAXTER LUER CAP BEING USED ON THE DEVICE¿S LUER. THE CUSTOMER DID NOT USE DEVICE'S BLUE WINGED LUER CAP. USING A NON BAXTER LUER CAP COULD POTENTIALLY CAUSE A LEAK AS THE CAP MAY NOT PROPERLY FIT THE FOLFUSOR DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.