UMBILICAL CATHETER
Received Jul 9, 2025 · Event occurred Jun 15, 2025
Report 2245270-2025-00068 · MDR key 22461728
Product problems
- Malposition of Device
- Positioning Problem
- Migration
- Malposition of Device
- Positioning Problem
- Migration
Patient
NA · Unknown
- Discomfort
- Ascites
- Abdominal Distention
- Discomfort
- Ascites
- Abdominal Distention
Narrative
Additional Manufacturer Narrative
THE INVOLVED UMBILICAL CATHETER WAS DISCARDED. THIS SERIOUS ADVERSE EVENT IS CAUSED BY A MISINTERPRETATION OF THE INITIAL RADIOGRAPHIC X-RAY CONTROL. THE UMBILICAL CATHETER'S MALPOSITION WAS NOT IDENTIFIED. THE BATCH REVIEW COULD NOT BE PERFORMED AS THE CUSTOMER DID NOT PROVIDE A BATCH NUMBER. DURING THE MANUFACTURING PROCESS OF UMBILICAL CATHETERS, 100% TESTS ARE CARRIED OUT ON EACH CATHETER. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP, MARKING THE CATHETERS, TIGHTNESS, AND NON-OBSTRUCTION. IN ADDITION, UMBILICAL CATHETERS ARE TESTED BY SAMPLING: TO CHECK THE TENSILE STRENGTH ACCORDING TO ISO 10555-1 NORM'S SPECIFICATION >10N. TO CHECK THE ABSENCE OF LIQUID LEAKAGE (3BAR/30 SECONDS) AND AIR LEAKAGE, ACCORDING TO ISO 10555-1 NORM. OUR UMBILICAL CATHETERS ARE COMPLIANT TO ISO 10555-1 NORM. BASED ON THIS INVESTIGATION, THE ROOT CAUSE IS NOT TRACED TO A DEVICE DEFECT BUT RATHER TO A USER MISTAKE. THEREFORE, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. FURTHERMORE, IT IS AN ISOLATED CASE.
Description of Event or Problem
AT BIRTH, A VENOUS UMBILICAL CATHETER WAS INSERTED ON A PREMATURE NEWBORN (25SA + 4 DAYS) IN PERIPHERAL POSITION, AS IT WAS IMPOSSIBLE TO PLACE IT IN A CENTRAL POSITION. DESPITE DIFFICULTIES, VENOUS BLOOD RETURN WAS FINALLY OBTAINED, BLOOD TEST WAS PERFORMED. ON INITIAL X-RAY CONTROL, THE CATHETER WAS INTERPRETED AS PLACED IN A PERIPHERAL POSITION, BUT AFTERWARDS A CONFUSION BETWEEN THE CATHETER (WHICH EXTENDS TOWARDS THE PELVIS AND WHOSE TIP IS NOT VISUALIZED) AND A SCOPE ELECTRODE CABLE (SLIGHTLY SIMILAR TONE ON X-RAY) WAS IDENTIFIED. CLINICAL DETERIORATION ON 16 JUNE, INCREASED O2 REQUIREMENTS, DISCOMFORT, ABDOMINAL DISTENSION. PERITONEUM EFFUSION WITH SPONTANEOUS RESOLUTION AND WITHOUT SERIOUS GRAVITY. THE EFFUSION WAS DETECTED ON ABDOMINAL ULTRASOUND AND FOLLOW-UP X-RAY, WHICH REVEALED THE KTVO IN AN ABNORMAL POSITION (PERITONEUM). QUICK STABILIZATION OF THE CHILD AFTER INTUBATION, ANALGESIC TREATMENT, PLACEMENT OF ANOTHER VASCULAR ACCESS AND REMOVAL OF THE UMBILICAL CATHETER.