UMBILI-CATH
Received May 31, 2022
Report 1718873-2022-00003 · MDR key 14549019
Device
Generic name
Umbilical Catheter
Manufacturer
Utah Medical Products, IncCatalog number
4275005
Lot number
1213248
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
5 DA · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING USE THE HUB POPPED OFF THE CATHETER TWICE. DUE TO THE HUB POP OFF THE CARDIAC SURGICAL TEAM REMOVED THE CATHETER FROM THE PATIENT. DURING THE REMOVAL OF THE CATHETER A PIECE OF THE TUBING BROKE OFF THE CATHETER AND REMAINED IN THE PATIENT. THE PATIENT REQUIRED SURGERY TO REMOVE THE SEVERED PIECE OF CATHETER TUBING.
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE A SEVERED SEGEMENT OF A CATHETER TUBE FROM THE PATIENT. THE PRODUCT IFU HAS INSTRUCTIONS FOR THE SAFE REMOVAL OF THE CATHETER FROM THE PATIENT.