UMBILICAL CATHETER

Additional Manufacturer Narrative

THE INVOLVED UMBILICAL CATHETER IS NOT AVAILABLE. FROM THE DESCRIPTION, THIS SERIOUS ADVERSE EVENT IS CLEARLY RELATED TO THE MALPOSITION OF THE UMBILICAL CATHETER. IT IS NOT TRACED TO A DEFECT OF OUR DEVICE. 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. THE HISTORICAL DATA ANALYSIS OF COMPLAINTS THESE LAST 3 YEARS, ON THIS REFERENCE DOES NOT SHOW ANY SIMILAR INCIDENT. AT THIS TIME, NO CORRECTIVE ACTION HAS BEEN INITIATED, AS THERE IS NO EVIDENCE INDICATING A CONNECTION BETWEEN THE ISSUE AND THE DEVICE.

Description of Event or Problem

A PREMATURE NEWBORN 34 WEEKS + 2 DAYS, WITH A BIRTH WEIGHT OF 1480G, WAS TRANSFERRED TO NEONATAL INTENSIVE CARE AT A SECOND HOSPITAL ON 1 DAY OF LIFE FOR SURGICAL MANAGEMENT OF AN ANORECTAL MALFORMATION WITH RECTOVAGINAL FISTULA. ON ADMISSION, HER CLINICAL CONDITION WAS STABLE AND PARENTERAL NUTRITION IS ADMINISTERED THROUGH UMBILICAL VENOUS CATHETER INSERTED AT BIRTH BY THE FIRST HOSPITAL. THE DAY AFTER ADMISSION, THE PATIENT IS OPERATED ON TO DILATE THE FISTULA. THE OPERATION IS GOING WELL AND ALLOWS EVACUATION OF FAECES. ON DAY 2 OF ADMISSION, SHE SUFFERED A CARDIORESPIRATORY ARREST DUE TO TAMPONADE OF IATROGENIC ORIGIN (PERFUSO- PERICARDIUM RELATED TO MALPOSITION OF THE UMBILICAL VENOUS CATHETER). THE EVOLUTION IS UNFAVORABLE DESPITE CARDIOPULMONARY RESUSCITATION STARTED EARLY AND PERICARDIAL DRAINAGE. THE PREMATURE DIED.

Description of Event or Problem

A PREMATURE NEWBORN 34 WEEKS + 2 DAYS, WITH A BIRTH WEIGHT OF 1480G, WAS TRANSFERRED TO NEONATAL INTENSIVE CARE AT A SECOND HOSPITAL ON 1 DAY OF LIFE FOR SURGICAL MANAGEMENT OF AN ANORECTAL MALFORMATION WITH RECTOVAGINAL FISTULA. ON ADMISSION , HER CLINICAL CONDITION WAS STABLE AND PARENTERAL NUTRITION IS ADMINISTERED THROUGH UMBILICAL VENOUS CATHETER INSERTED AT BIRTH BY THE FIRST HOSPITAL. THE DAY AFTER ADMISSION, THE PATIENT IS OPERATED ON TO DILATE THE FISTULA. THE OPERATION IS GOING WELL AND ALLOWS EVACUATION OF FAECES . ON DAY 2 OF ADMISSION , SHE SUFFERED A CARDIORESPIRATORY ARREST DUE TO TAMPONADE OF IATROGENIC ORIGIN (PERFUSO- PERICARDIUM RELATED TO MALPOSITION OF THE UMBILICAL VENOUS CATHETER). THE EVOLUTION IS UNFAVORABLE DESPITE CARDIOPULMONARY RESUSCITATION STARTED EARLY AND PERICARDIAL DRAINAGE. THE PREMATURE DIED.

Additional Manufacturer Narrative

THIS MDR WAS INITIALLY SENT UNDER NUMBER 2245270-2025-00035 ON APRIL 22, 2025. THIS REPORT REQUIRE A CORRECTION. CORRECTION: THE PRODUCT LOT NUMBER ASSOCIATED WITH THE COMPLAINT SHOULD BE 290523PB . THE PREVIOUS REPORT LISTED 290325PB ERRONEOUSLY. THE INVOLVED UMBILICAL CATHETER IS NOT AVAILABLE. FROM THE DESCRIPTION, THIS SERIOUS ADVERSE EVENT IS CLEARLY RELATED TO THE MALPOSITION OF THE UMBILICAL CATHETER. IT IS NOT TRACED TO A DEFECT OF OUR DEVICE. 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. THE HISTORICAL DATA ANALYSIS OF COMPLAINTS THESE LAST 3 YEARS, ON THIS REFERENCE DOES NOT SHOW ANY SIMILAR INCIDENT. AT THIS TIME, NO CORRECTIVE ACTION HAS BEEN INITIATED, AS THERE IS NO EVIDENCE INDICATING A CONNECTION BETWEEN THE ISSUE AND THE DEVICE.