UMBILICAL CATHETER
Received Jul 1, 2025 · Event occurred Mar 25, 2025
Report 2245270-2025-00061 · MDR key 22370331
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
2 DA · Male
- Emotional Changes
- Rash
- Malaise
- Emotional Changes
- Rash
- Malaise
Narrative
Description of Event or Problem
CONCERN DESCRIPTION: NOTED A LEAK AT THE 7CM MARK. BUBBLE OF FLUID FORMED. WIPED WITH STERILE GAUZE, AND WATCH THE SITE AND SAW ANOTHER BUBBLE FORM LEADING TO A LEAK.
Additional Manufacturer Narrative
THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.
Description of Event or Problem
CONCERN DESCRIPTION: NOTED A LEAK AT THE 7CM MARK. BUBBLE OF FLUID FORMED. WIPED WITH STERILE GAUZE, AND WATCH THE SITE AND SAW ANOTHER BUBBLE FORM LEADING TO A LEAK.
Additional Manufacturer Narrative
THE COMPLAINT AND RETURNED SAMPLE WERE SUBMITTED TO THE MANUFACTURER, VYGON FRANCE, FOR EVALUATION. THE FOLLOWING IS A SUMMARY OF THEIR INVESTIGATION: THE UMBILICAL CATHETER WAS RECEIVED IN A BIOHAZARD BAG. THE GREEN LINE WAS CONNECTED TO A THIRD-PARTY EXTENSION FITTED WITH A RED CAP, AND THE YELLOW LINE WAS CONNECTED TO A THIRD-PARTY EXTENSION FITTED WITH A PINK CAP. BOTH LINES WERE CLAMPED. DRY RESIDUES AND A BROWNISH FLUID WERE VISIBLE ON THE ENTIRE DEVICE. ADHESIVE WAS OBSERVED AT MARKERS 7 AND 9, AND A THREAD WAS PRESENT NEAR MARKER 6. SEVERAL RINSES WITH HOT WATER WERE PERFORMED IN AN ATTEMPT TO UNCLOG THE CATHETER. NO ANOMALIES WERE OBSERVED ON THE TUBE, AND THE RESULTS WERE COMPLIANT. THE DEVICE WAS THEN CONNECTED TO AN AIR INLET AND SUBMERGED IN WATER WITH THE TUBE'S END CLAMPED. A PRESSURE TEST WAS CONDUCTED AT 500 MBAR, FOLLOWED BY 1 BAR. NO LEAKAGE WAS OBSERVED, AND THE RESULTS WERE COMPLIANT. THE REVIEW OF THE BATCH DOCUMENTATION REVEALED NO DISCREPANCIES. FURTHERMORE, ALL OUR CATHETERS UNDERGO 100% LEAK AND PATENCY TESTING DURING THE MANUFACTURING PROCESS. AS THE SAMPLE COMPLIES WITH SPECIFICATIONS, THE CLAIM IS CONSIDERED UNJUSTIFIED. THE HISTORICAL DATA ANALYSIS SHOWS THAT THERE IS NO SIMILAR CLAIMS THAT HAVE BEEN REPORTED FOR THIS BATCH. CORRECTIVE ACTION: BASED ON VYGON FRANCE'S INVESTIGATION, NO LEAKAGE WAS OBSERVED IN THE RETURNED SAMPLE; THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.