UMBILICAL CATHETER SNGL LUMEN 3.5FR

Additional Manufacturer Narrative

A DECONTAMINATED SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. BECAUSE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. UPON A VISUAL EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; THE CATHETER TUBE WAS BROKEN NEAR THE 6CM MARK. A ROOT CAUSE ANALYSIS INDICATED THAT THIS COMPLAINT WAS USER RELATED.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PRODUCT BROKE DURING USE. PER ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE BEING PERFORMED WAS A UVC REMOVAL. THE CATHETER SNAPPED/BROKE INTO 2 PIECES. THE DOCTOR WAS ABLE TO GRAB THE REMAINDER OF THE LINE THAT WAS STILL IN SITU WITH FORCEPS. SCANT BLOOD LOSS WAS NOTED FROM THE LINE. THE DOCTOR WAS ABLE TO APPLY A CLAMP AND COMPLETE REMOVAL OF THE REMAINING LINE. THE TIP WAS INTACT UPON REMOVAL. THE UVC WAS IN SITU AT 6CM AND THE LINE APPEARED TO HAVE BROKEN BETWEEN THE 5CM AND 6CM MARKING, JUST ABOVE WHERE THE LINE WAS SUTURED. NO FURTHER BLEEDING WAS NOTED FROM THE SITE ONCE THE LINE WAS FULLY REMOVED. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THERE WAS NO MEDICATION ADMINISTERED. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.