UMBILICAL CATHETER
Received Oct 30, 2025 · Event occurred Oct 5, 2025
Report 2245270-2025-00141 · MDR key 23427285
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INCRIMINATED SAMPLE WAS RECEIVED AND ANALYZED. A BLOOD STAIN WAS OBSERVED AT THE TIP OF THE CATHETER, WITH NO EVIDENCE OF BLOOD PRESENT IN THE MIDDLE SECTION OR AT THE BASE/HUB OF THE CATHETER. NO VISUAL OR FUNCTIONAL ANOMALIES WERE IDENTIFIED IN EITHER THE HUB OR THE CATHETER TUBING. A DETAILED VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED, INCLUDING VERIFICATION OF THE TIP ROUNDNESS. ALL MEASURED PARAMETERS WERE WITHIN THE APPLICABLE SPECIFICATIONS. NO ANOMALIES WERE DETECTED, AND THE PRODUCT WAS CONFIRMED TO BE FULLY COMPLIANT WITH SPECIFICATIONS. A REVIEW OF THE BATCH DOCUMENTATION CONFIRMED THAT NO IRREGULARITIES WERE IDENTIFIED DURING THE QUALITY CONTROL PROCESS. ADDITIONALLY, NO OTHER COMPLAINTS ASSOCIATED WITH THIS BATCH HAVE BEEN REPORTED TO DATE. CORRECTIVE ACTION: BASED ON VYGON FRANCE'S INVESTIGATION, NO ANOMALIES WERE DETECTED, AND THE PRODUCT WAS FOUND TO BE FULLY WITHIN SPECIFICATIONS. THEREFORE, NO FURTHER CORRECTIVE ACTION HAS BEEN INITIATED AT THIS TIME.
Description of Event or Problem
ASSISTED BESIDE NURSE TO REMOVE #5 FR VYGON SINGLE LUMEN UVC. TIP INTACT - 1.5" OF DARK BLOOD NOTED INSIDE END OF LINE + ON TIP WAS A SMALL FIBROUS APPEARING [?]'CLOT''. SHOWN TO NEONATOLOGIST ON CALL AND CRN. PRODUCT SAVED TO SHOW PTM. CATHETER REMOVED.
Description of Event or Problem
ASSISTED BESIDE NURSE TO REMOVE #5 FR VYGON SINGLE LUMEN UVC. TIP INTACT - 1.5" OF DARK BLOOD NOTED INSIDE END OF LINE + ON TIP WAS A SMALL FIBROUS APPEARING [?]'CLOT''. SHOWN TO NEONATOLOGIST ON CALL AND CRN. PRODUCT SAVED TO SHOW PTM. CATHETER REMOVED.
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.