DUAL-LUMEN UVC CATH

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

CUSTOMER REPORTS: A SLOW LEAK OCCURRED WITH THE UMBILICAL VESSEL CATHETER (UVC) OVERNIGHT. THE DOCTOR WAS NOTIFIED WHEN IT WAS FOUND. IN THE MORNING A LOW GLUCOSE LEVEL RESULT AND INCREASED LEAKING WAS NOTICED. PER DOCTOR'S ORDERS, THE UVC WAS PULLED AFTER A PERIPHERAL INTRAVENOUS LINE (PIV) PLACEMENT WAS OBTAINED.

Additional Manufacturer Narrative

UPDATES MADE TO THE FOLLOWING FIELDS PER ADDITIONAL INFORMATION RECEIVED AFTER THE INITIAL REPORT WAS SUBMITTED: D4: MODEL NUMBER D4: CATALOG NUMBER D4: UDI #

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. A SAMPLE ANALYSIS WAS NOT POSSIBLE AS THERE WAS NO PHOTOGRAPHS OR SAMPLES PROVIDED FOR EVALUATION. WITHOUT A SAMPLE TO EVALUATE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED ISSUE, DETERMINE A ROOT CAUSE OR RELATE IT TO A MANUFACTURING PROCESS. ALL ASSOCIATED LOT DOCUMENTATION WAS CAREFULLY REVIEWED; NO ISSUES OR DISCREPANCIES WERE FOUND RELATED TO THE REPORTED COMPLAINT. CURRENT PROCESS CONTROLS ARE EXECUTED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS TO MEET QUALITY ACCEPTANCE CRITERIA. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR THE PROCESS, CUSTOMER COMPLAINTS AND FEEDBACK NOTIFICATIONS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. IN THE CASE OF A REPEATED ISSUE AND/OR RECURRENCE, A NEW INVESTIGATION FOR THE SPECIFIC EVENTS WOULD BE CARRIED OUT FOR EACH CASE.