MalfunctionFOS
3.5FR DUAL-LUMEN UVC CATH
Received Sep 8, 2021
Report 3009211636-2021-00762 · MDR key 12438451
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
CovidienModel number
8888160531Catalog number
8888160531
Lot number
2011900076
Product problems
- Material Puncture/Hole
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.
Description of Event or Problem
THE CUSTOMER REPORTED THERE WAS A HOLE IN THE TUBING OF THE CENTRAL LINE. THERE WAS NO HARM TO THE PATIENT.