UMBILICAL CATHETER SINGLE LUMEN 5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THE LINE WAS FLUSHED WITH NS AND PLACED IN UMBILICAL VEIN. BUBBLES WERE NOTED WHEN PULLING BACK ON THE SYRINGE AND THERE WAS LEAKING AT THE CATHETER HUB. NO AIR/BUBBLES REACHED THE PATIENT. THE LINE WAS IMMEDIATELY REMOVED AND A NEW PRIMED FOOTPRINT LINE WAS PLACED WITHOUT DIFFICULTY. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. ONE PHYSICAL SAMPLE OF ITEM CODE 8888160341 WITH LOT NUMBER 2030100064 WAS RECEIVED FOR INVESTIGATION. THE CATHETER WAS VISUALLY INSPECTED AND SUBMITTED TO UNDERWATER TESTING TO IDENTIFY A POSSIBLE LEAK; HOWEVER, THE TEST DID NOT SHOW ANY DEVIATIONS. THE SAMPLE PASSED THE TEST, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.