UMBILICAL CATHETER SNGL LUMEN 3.5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2024 A 3.5 FR UMBILICAL CATHETER WAS PLACED BY STERILE TECHNIQUE IN AN UMBILICAL ARTERY AND SUTURED IN PLACE. THE CATHETER WAS INSERTED UP TO THE 13CM MARK. ON (B)(6) 2024 THE CATHETER WAS REMOVED BY THE BEDSIDE RN, SUTURES REMOVED PRIOR TO REMOVAL. DURING REMOVAL, THE CATHETER HAD A CLEAN BREAK AT APPROXIMATELY THE 9.25 CM MARK. THE RN HAD A STERILE HEMOSTAT AVAILABLE AND WAS ABLE TO ATTACH TO THE REMAINING CATHETER AND REMOVE THE REMAINDER FROM THE UMBILICUS. NO HARM WAS DONE. THE RN REPORTED THE REMOVAL PROCESS WENT SMOOTHLY PRIOR TO THE BREAK, NO INCREASE IN TENSION WHEN REMOVING THE LINE. ON 11MAR2024 THE INITIAL REPORTER STATED THAT THE CATHETER BROKE INTO TWO SEPARATE PIECES WHICH THE NURSE WAS ABLE TO SEE AT ALL TIMES DURING THE TIME IT WAS BROKEN THEN REMOVED. THE RN REPORTED THE REMOVAL WAS THE SAME AS FAR AS THE REMOVAL OF OTHER UMBILICAL LINES. NO FURTHER TREATMENT REQUIRED. THE CUSTOMER CONFIRMED IT WAS A STANDARD REMOVAL DUE TO THE ORDER TO DISCONTINUE THE LINE.

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE TO US, WE WERE ABLE TO CONFIRM THE EVENT AND DETERMINED THAT: THE RETURNED DEVICE WAS BROKEN BETWEEN POINTS 10 AND 9. NO OTHER DAMAGE WAS NOTED. BASED ON AVAILABLE INFORMATION AND REVIEW OF THE PROCESS, CONTROLS AND DOCUMENTATION, AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.