NI

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED ELASTOMERIC DEVICE LEAKED ON PATIENT'S ABDOMEN. THE LOCATION OF THE LEAK WAS DESCRIBED AS "THE LOWER PORTION OF THE WHITE CONNECTION ON THE INFUSER TUBING. THERE WAS A LEAK COMING FROM CHEMO BOTTLE LINE". THE ISSUE OCCURRED DURING PATIENT INFUSION. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.