UMBILICAL CATHETER SINGLE 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. THERE WAS NO SAMPLE RECEIVED FOR EVALUATION. BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT. IN THE MEANTIME, ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD NOTICED UVC LINE WAS LEAKING AT CLAVE SITE. PER CUSTOMER, THEY VERIFIED THE CONNECTIONS AND WERE TIGHT AT START OF THE SHIFT. THE CHARGE WAS NOTIFIED, AND TRANSPORT NURSE WAS CALLED. FELLOW WAS THEN NOTIFIED AND CAME TO ASSESS THE PATIENT. A DECISION WAS MADE TO INSERT A PICC LINE AND UVC WAS REMOVED. THE CUSTOMER FURTHER STATED THAT THE CONNECTOR BEING USED WAS MC100 ICU MEDICAL.