UMBILICAL CATHETER DUAL LUMEN 3.5FR
Received Feb 17, 2023 · Event occurred Feb 15, 2023
Report 3009211636-2023-00809 · MDR key 16397241
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal HealthModel number
8888160531Catalog number
8888160531
Lot number
2202400084
Product problems
- Material Puncture/Hole
- Material Puncture/Hole
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT. IN THE MEANTIME, ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE DUAL LUMEN 3.5 FR UVS HAD A HOLE IN BELOW THE JUNCTION OF THE BIFURCATION AND WAS LEAKING ON TO THE BED. THE UVC WAS REMOVED AND HAD TO BE REPLACED. NO INJURY REPORTED.