UMBILICAL CATHETER DUAL LUMEN 5FR

Additional Manufacturer Narrative

THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A FAULTY DUAL LUMEN UVC WAS FOUND DURING LINE PLACEMENT. PER CUSTOMER, INFANT TO RECEIVE A DUAL LUMEN UVC AND ADVANCED PRACTICE PROVIDER (APP) WAS UNABLE TO FLUSH HEPARINIZED SALINE THROUGH BLUE (SECONDARY) LUMEN. NEW CATHETER UTILIZED SUCCESSFULLY. THERE WAS NO HARM REPORTED TO THE PATIENT INVOLVED.

Additional Manufacturer Narrative

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