UMBILICAL CATHETER

Additional Manufacturer Narrative

THE INVOLVED UMBILICAL CATHETER IS AVAILABLE; WE ARE WAITING FOR IT FOR THE INVESTIGATION. 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, 35 UMBILICAL CATHETERS ARE TESTED BY SAMPLING: -TO CHECK THE TENSILE STRENGTH ACCORDING TO ACCORDING TO NF EN ISO 10555-1 SPECIFICATION >10N. ALL RESULTS ARE COMPLIANT. -TO CHECK THE ABSENCE OF LIQUID LEAKAGE (3BAR/30 SECONDS) AND AIR LEAKAGE WERE DONE, ACCORDING TO NF EN ISO 10555-1. ALL RESULTS COMPLIED (NO AIR OR LIQUID LEAKAGE). THE HISTORICAL DATA ANALYSIS OF COMPLAINTS ON THIS BATCH DOES NOT SHOW ANY COMPLAINT. THIS IS THE FIRST COMPLAINT FROM (B)(4) UNITS OF THIS BATCH SOLD SINCE (B)(6) 2024. FROM THE DESCRIPTION OF THIS INCIDENT, AS THE CATHETER BROKE DURING REMOVAL PROCEDURE, THE MOST LIKELY ROOT CAUSE SEEMS TO BE TRACED TO THE REMOVAL PROCEDURE AND NOT TO A CATHETER DEFECT. IT WAS IN USE FOR 7 DAYS, FUNCTIONING CORRECTLY. WE ARE WAITING FOR THE INVOLVED SAMPLE FOR INVESTIGATION.

Description of Event or Problem

THE INCIDENT OCCURRED DURING THE REMOVAL PROCEDURE OF VENOUS UMBILICAL CATHETER, 7 DAYS AFTER ITS INSERTION AND USE. THE PRACTICIAN WENT TO OPERATING ROOM TO REMOVE THE FIXATION, HE RETRACTED THE CATHETER A LITTLE TO VERIFY IF IT WAS EASY TO REMOVE OR IF IT NEEDED TO BE SLIGHTLY MOISTENED FOR PROPER REMOVAL. HE TOOK AN ISOPANIL (TOWEL IMPREGNATED WITH 70% ISOPROPYL ALCOHOL USED FOR CLEANING, DISINFECTION, AND PREPARATION OF THE SKIN) TO MAKE THE VERIFICATION AGAIN AND ON RETRACTING IT AGAIN, AT THAT MOMENT THE CATHETER BROKE, THE TIP OF THE CATHETER WAS STILL VISIBLE. TWO SUPERVISORS WERE CALLED. WE TOOK OUT THE EQUIPMENT USED TO PASS THE UMBILICAL CATHETER AND TOOK THE FORCEPS TO TRY TO REMOVE IT, BUT THE CATHETER WAS RETRACTING AS THE SECONDS PASSED. WE CALLED THE NEONATOLOGIST AND THE PEDIATRICIAN, WHO ALSO TRIED TO REMOVE THE CATHETER WITH FORCEPS, BUT IT WAS UNSUCCESSFUL. WE DECIDED TO CONTACT THE INTERVENTIONAL RADIOLOGIST WHO REQUESTED THE X-RAY AND DECIDED TO PERFORM THE REMOVAL PROCEDURE ON (B)(6) 2025. THE CATHETER WAS REMOVED WITHOUT COMPLICATION.

Additional Manufacturer Narrative

CORRECTION: THE CORRECT PRODUCT CODE ASSOCIATED WITH THE COMPLAINT IS 270.05, NOT 270.03. THE INITIAL REPORT ERRONEOUSLY LISTED THE CODE AS 270.03. WE RECEIVED THE INVOLVED UMBILICAL CATHETER. THE CATHETER IS BROKEN WITH A COMPLETE FRACTURE. IN TERMS OF APPEARANCE, THE CATHETER HAS NORMAL RIGIDITY AND NO ABNORMALITIES WERE DETECTED ON THE SURFACE OF THE TUBE. THE FRACTURE IS IDENTIFIED APPROXIMATELY AT 95 MM ABOVE THE DISTAL TIP, BETWEEN MARKING 9 AND 10. ON EXAMINATION UNDER THE MICROSCOPE THE FRACTURED SURFACES WERE FOUND TO HAVE AREAS OF SMOOTHS AND ROUGH ASPECTS. A CUT IN THE WALL OF THE TUBE PARALLEL TO THE AXIS OF THE CATHETER IS ALSO VISIBLE. THIS SMOOTH ASPECT INDICATES THAT THE CATHETER HAS COME INTO CONTACT WITH A SHARP IMPLEMENT ( FOR EXAMPLE, A SCALPEL BLADE, SCISSORS), WHICH MAY HAVE OCCURRED DURING INSERTION OR DURING DRESSING PROCEDURE. FURTHERMORE, NO SIGN OF OBVIOUS MANUFACTURING MATERIAL WEAKNESS, WAS IDENTIFIED DURING CATHETER EXAMINATION. IN THE IFU THERE IS A WARNING AS FOLLOWS: DO NOT APPLY SHARP OR ROUGH-EDGED INSTRUMENTS DIRECTLY TO THE CATHETER: EVEN A MINOR CUT COULD TEAR IT OR BREAK IT. DO NOT DELIBERATELY CUT THE CATHETER. THE BATCH RECORD REVIEW SHOWS THAT ALL PRODUCTS ARE IN COMPLIANCE WITH THE SPECIFICATION AND ISO NORM. THERE IS NO NON-CONFORMITY OR DEVIATION. 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, 35 UMBILICAL CATHETERS ARE TESTED BY SAMPLING: TO CHECK THE TENSILE STRENGTH ACCORDING TO ACCORDING TO NF EN ISO 10555-1 SPECIFICATION >10N. ALL RESULTS ARE COMPLIANT. TO CHECK THE ABSENCE OF LIQUID LEAKAGE (3BAR/30 SECONDS) AND AIR LEAKAGE WERE DONE, ACCORDING TO NF EN ISO 10555-1. ALL RESULTS COMPLIED (NO AIR OR LIQUID LEAKAGE). A REVIEW OF HISTORICAL COMPLAINT DATA FOR THIS BATCH REVEALED NO PRIOR COMPLAINTS. THE ROOT CAUSE OF THIS INCIDENT IS NOT DUE TO A CATHETER QUALITY DEFECT BUT TRACED TO THE USER, TO AN IMPROPER PROCEDURE. THEREFORE, NO CORRECTIVE ACTION HAS BEEN INITIATED AT THIS TIME.

Description of Event or Problem

THE INCIDENT OCCURRED DURING THE REMOVAL PROCEDURE OF VENOUS UMBILICAL CATHETER, 7 DAYS AFTER ITS INSERTION AND USE. THE PRACTICIAN WENT TO OPERATING ROOM TO REMOVE THE FIXATION, HE RETRACTED THE CATHETER A LITTLE TO VERIFY IF IT WAS EASY TO REMOVE OR IF IT NEEDED TO BE SLIGHTLY MOISTENED FOR PROPER REMOVAL. HE TOOK AN ISOPANIL (TOWEL IMPREGNATED WITH 70% ISOPROPYL ALCOHOL USED FOR CLEANING, DISINFECTION, AND PREPARATION OF THE SKIN) TO MAKE THE VERIFICATION AGAIN AND ON RETRACTING IT AGAIN, AT THAT MOMENT THE CATHETER BROKE, THE TIP OF THE CATHETER WAS STILL VISIBLE. TWO SUPERVISORS WERE CALLED. WE TOOK OUT THE EQUIPMENT USED TO PASS THE UMBILICAL CATHETER AND TOOK THE FORCEPS TO TRY TO REMOVE IT, BUT THE CATHETER WAS RETRACTING AS THE SECONDS PASSED. WE CALLED THE NEONATOLOGIST AND THE PEDIATRICIAN, WHO ALSO TRIED TO REMOVE THE CATHETER WITH FORCEPS, BUT IT WAS UNSUCCESSFUL. WE DECIDED TO CONTACT THE INTERVENTIONAL RADIOLOGIST WHO REQUESTED THE X-RAY AND DECIDED TO PERFORM THE REMOVAL PROCEDURE ON (B)(6) 2025. THE CATHETER WAS REMOVED WITHOUT COMPLICATION.