UMBILICAL CATHETER

Additional Manufacturer Narrative

THE INVOLVED UMBILICAL CATHETER WAS DISCARDED. THEREFORE, THE INVESTIGATION WILL BE LIMITED. THE BATCH REVIEW DOES NOT SHOW ANY NON-CONFORMITY . THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. ALL CONTROLS ARE COMPLIANT, INCLUDING THE 100% TESTS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP , MARKING THE CATHETERS, TIGHTNESS AND NON-OBSTRUCTION. IN ADDITION, 25 UMBILICAL CATHETERS ARE TESTED BY SAMPLING, TO CHECK THE ABSENCE OF LIQUID LEAKAGE (3BAR/30 SECONDS) AND AIR LEAKAGE WERE DONE, ACCORDING TO NF EN ISO 10555-1. ALL THE RESULTS COMPLIED WITH THE SPECIFICATIONS (NO AIR OR LIQUID LEAKAGE). FROM PREVIOUS INVESTIGATIONS, WE ARE AWARE OF THE FOLLOWING POSSIBLE CAUSE OF THE CRACK IDENTIFIED:MECHANICAL STRESS - MANUAL OVER-TIGHTENING OF THE MALE LUER OF THE CONNECTING DEVICE INTO THE FEMALE HUB. AS THE CONNECTION IS OVER TIGHTENED, THE MALE LUER OF THE CONNECTING DEVICE RIDES UP OVER THE SURFACE OF THE FEMALE LUER. THIS MECHANISM CREATES HOOP STRESS IN THE BODY OF THE FEMALE LUER, RESULTING IN A FRACTURE IN THE WALL OF THE FEMALE LUER. SUCH MECHANICAL STRESS COMBINED TO A CHEMICAL STRESS (LIPIDS) IS THE MOST PROBABLE CAUSE OF A CRACK. THE HISTORICAL DATA ANALYSIS OF SIMILAR INCIDENT (CRACK/LEAKAGE) THESE 3 LAST YEARS, SHOWS THAT THERE IS ONLY ONE IN 2021 DUE TO THE USER ERROR. THE INCIDENT OCCURRED WHEN DISCONNECTING AN INFUSION LINE WITH CLAMPS; MECHANICAL STRESS APPEARS TO BE THE MOST LIKELY CAUSE OF THIS INCIDENT. BASED ON THIS INVESTIGATION, THE MOST LIKELY CAUSE SEEMS TO BE TRACED TO THE CONDITION OF USE AND NOT TO A DEVICE DEFECT. FURTHERMORE, IT IS AN ISOLATED CASE.

Description of Event or Problem

AFTER THE CATHETER INSERTION OF 2 DAYS IT IS STATED THAT THERE ARE CRACKING AND LEAKAGE FROM THE HUB OF THE UMBILICAL CATHETER DURING TPN FLUID EXCHANGE AND BLOOD LEAKAGE OCCURS. 2 DAYS USAGE OF CATHETER AND THEY USED ONLY TPN. THEY HAVE TO REMOVE CATHETER DUE TO THE CRACKING AND LEAKAGE AND THEY OPENED NEW NON CENTRAL VENOUS ACCESS TO PATIENT. THEY RE-INVASIVELY OPENED A NEW VASCULAR ACCESS, WHICH CAUSED PAIN AND STRESS TO THE PATIENT AND DELAYED TREATMENT. THERE IS A VEIN VALVE AT THE HUB OF THE CATHETER AND THIS IS CONNECTED TO THE INFUSION LINE. THE INFUSION LINE IS CONNECTED TO THE PLUM 360 MODEL OF ICU MEDICAL. THE UMBILICAL CATHETER WAS MADE AS A VENOUS INTERVENTION AND AFTER 2 DAYS, CRACKING AND LEAKAGE WAS SEEN AT THE HUB OF THE CATHETER. TPN CONTENT : 20% DEXTROSE, 30% DEXTROSE, 10% PRIMENE, TRACUTIL, MAGNESIUM, 20% LIPID CLINOLEIC.