UMBILICAL CATHETER SNGL LUMEN 3.5FR
Received Oct 5, 2023 · Event occurred Sep 15, 2023
Report 3009211636-2023-00825 · MDR key 17876328
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal HealthModel number
8888160333Catalog number
8888160333
Lot number
2010400050
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT 10 CM OF THE 3.5FR CATHETER WAS LEFT IN THE BODY WHEN THE PHYSICIAN EXTRACTED THE CATHETER. THERE WERE NO ADVERSE REACTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED, INFORMATION ABOUT HOW THE CATHETER PART WAS LEFT IN THE BODY, IF ALL PIECES WERE RETRIEVED AND MEDICAL INTERVENTION REQUIRED IS UNKNOWN.
Additional Manufacturer Narrative
A USED SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE SAMPLE, THE DEFECT WAS CONFIRMED; THE CATHETER WAS BROKEN ON ITS TUBE; SPLIT IN TWO. A ROOT CAUSE ANALYSIS INDICATED THAT THIS COMPLAINT IS USER RELATED.