MalfunctionFOS
UMBILICAL CATHETER
Received Jun 9, 2026 · Event occurred May 25, 2026
Report 2245270-2026-00075 · MDR key 25444395
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- Insufficient Information
Narrative
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
UVC INSERTED, FOUND TO BE TOO DEEP IN PATIENT, WHEN DOCTOR PULLED LINE BACK AND FLUSHED UVC LINE AGAIN, NOTICED THAT THERE WAS LEAKING BETWEEN THE 11 & 12 CM MARK ON THE LINE.