MEDEX EXTENSION SETS MULTI LINE WITH FILTER

Additional Manufacturer Narrative

OTHER, OTHER TEXT: H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVENT PROBLEM AND EVALUATION CODES: UPDATED. THE COMPLAINT COULD NOT BE CONFIRMED AS NO SAMPLE WAS PROVIDED BY THE CUSTOMER. WITH NO PRODUCT RETURNED IN THIS CASE, THE CAUSAL FACTOR OF THE REPORTED ISSUE CANNOT BE ESTABLISHED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. IF THE PRODUCT IS RETURNED THE INVESTIGATION WILL BE REOPENED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO 1L BOLUS OF NORMAL SALINE IN HALLWAY BED ACROSS FROM NURSE'S STATION. WHILE INFUSING, DEFECTIVE IV TUBING BROKE IN HALF ABOUT 5 INCHES FROM HUB CONNECTION TO THE PATIENT. FLUID LEAKED OUT ONTO FLOOR AND BLOOD INTO TUBING STILL CONNECTED TO PATIENT. BREAK WAS NOTICED IMMEDIATELY AND TUBING WAS DISCONNECTED. FLUIDS CLEANED UP AND PROPERLY AND DISPOSED OF. NO HARM TO PATIENT, IV CATHETER UNDAMAGED AND REMAINED INTACT.

Additional Manufacturer Narrative

DEVICE LOT NUMBER, MANUFACTURE, AND EXPIRATION DATES ARE UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.