MEDEX MICRO BORE EXTENSION SET W/ MICRON FILTER

Additional Manufacturer Narrative

DEVICE EVALUATION: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. AWARENESS FOR FAILURE MODE ¿LEAKING AROUND THE FILTER AREA¿ WAS GIVEN TO PERSONNEL WHO PERFORM THE ASSEMBLY PROCESS OF THIS DEVICE.

Additional Manufacturer Narrative

D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. E1. INITIAL REPORTER FACILITY ADDRESS AND PHONE NUMBER: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS LEAKING AROUND THE FILTER AREA DURING THE INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM, ADVERSE EVENT REPORTED.