UMBILICAL CATHETER
Received Dec 13, 2024 · Event occurred Oct 21, 2024
Report 3007697249-2024-00006 · MDR key 20929016
Device
Generic name
Umbilical Catheter
Manufacturer
Footprint Medical Inc.Model number
UNKNOWNLot number
UNKNOWN
Product problems
- Break
- Break
Patient
1 DA · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT AVAILABLE FOR EVALUATION. INTERNAL INVESTIGATION INCLUDED REVIEWING THE REPORTED INCIDENT INFORMATION AND CATHETER MATERIAL INSPECTION RECORDS FOR MATERIALS THAT WERE POSSIBLY USED IN THE DEVICE EVENT. THE INVESTIGATION INDICATED NO EVIDENCE OF MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING RE-POSITIONING OF THE UMBILICAL CATHETER, AN 11CM PORTION BROKE. THE CATHETER PORTION BECAME LODGED NEAR THE VERTEBRAL ARTERY. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR) TO RETRIEVE THE CATHETER. THE PATIENT EXPIRED ON (B)(6) 2024.