MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE LINE CHANGE WAS DONE ON PATIENT AT START OF NIGHT, LATER FOUND THAT THE MICROCLAVE WAS LEAKING ON THE CVC WHITE LUMEN. UPON FURTHER INSPECTION NOTED THAT THE MICROCLAVE WAS CRACKED. PERFORMED ANOTHER LINE CHANGED. THE CRACKED MICROCLAVE WAS ALSO MISSING THE INNER SPONGY MATERIAL AND NOTED TO BE CRACKED. CAP WAS PLACED ON (B)(6) 2026 22:00 AND WAS NOTED LEAKING/CRACKED (B)(6) 2026 04:00 BY SAME RN WHO PLACED IT. WAS IN USE FOR 6 HOURS. IV INFUSING WAS 0.45 NS WITH HEPARIN AT 1ML/HR. NO IV MEDS WERE GIVEN. THE LEAKING WAS IN THE MIDDLE WHERE IT APPEARS 2 PIECES ARE BONDED. CONFIRMED THE SILICON SEAL IS MISSING BUT IT IS NOT LEAKING AT THAT LOCATION. NO VISIBLE CRACK SEEN IN MICROCLAVE UPON FOLLOW UP INSPECTION WITH FLUSHING MICROCLAVE. THE LINE WAS CHANGED BY THE NURSE. THERE WAS NO HARM TO THE PATIENT. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

LINE CHANGE WAS DONE ON PATIENT, LATER FOUND THAT THE MICROCLAVE WAS LEAKING ON THE CVC WHITE LUMEN, AND NOTED THAT THE MICROCLAVE WAS CRACKED.