FLUID SYSTEMS ACCESSORIES

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 AND H11. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF AIR ELIMINATING 1.2 MICROMETER SOLUTION FILTERS LEAKED AT THE SLIP CONNECTION TO UNSPECIFIED EXTENSION SETS. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP AT THE NICU DEPARTMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4 UDI #: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.