UMBILI-CATH
Received Nov 7, 2025 · Event occurred Oct 11, 2025
Report 1718873-2025-00003 · MDR key 23499913
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, Inc.Catalog number
4275005
Lot number
UNKNOWN
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A SURGERY WAS PERFORMED TO REMOVE THE REMAINING CATHETER SEGMENT FROM THE PATIENT. THE CLINICAL NURSE MANAGER STATED THE PATIENT WAS NOT HARMED. AFTER INVESTIGATION AT UTMD, THE RETURNED CATHETER HAD BEEN DAMAGED WITH AN INSTRUMENT JUST BELOW THE SUTURE SECURING IT AND THEN TORN. THE RETURNED CATHETER WAS TENSILE STRENGTH TESTED AT UTMD AND MET SPECIFICATIONS. THE IFU HAS PRECAUTIONS TO TAKE CARE NOT DAMAGE THE SOFT SILICONE CATHETER DURING USE. (SEE IFU 58078 REV. 022322).
Description of Event or Problem
THE SURGEON WAS CONSULTED DUE TO OOZING AROUND THE UMBILICAL CORD THAT WOULD NOT CORRECT WITH ANY INTERVENTION. WHILE REMOVING 5FR DOUBLE LUMEN UMBILICAL CATHETER IT BROKE, AND 3 CM REMAINED IN THE PATIENT'S UMBILICUS. PATIENT REQUIRED A TRIP TO THE OR TO REMOVE RETAINED UVC THAT HAD BROKEN OFF WHEN PEDS SURGERY HAD TRIED TO REMOVE IT. INCIDENTAL FINDING IF A URACHAL REMNANT WAS FOUND BY SURGEON. THIS WAS CAUSE OF DIFFICULTIES WITH UVC AND UAC PLACEMENTS AND POSSIBLY REASON WHY UVC BROKE WHEN PEDS SURGERY TRIED TO REMOVE IT. THE REMNANT WAS DISCARDED, BUT THE REMAINING SAMPLE IS AVAILABLE FOR EVALUATION.