UMBILICAL CATHETER SINGLE LUMEN 5FR
Received Mar 19, 2024
Report 3009211636-2024-00803 · MDR key 18938200
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal HealthModel number
8888160341Catalog number
8888160341
Lot number
2303100243
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE REPORTED LOT NUMBER SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QA DOCUMENTATION. ONE PRODUCT SAMPLE WAS PROVIDED BY THE CUSTOMER. THE SAMPLE SHOWED SIGNS OF USE SUCH AS A TAPE IN THE TUBE AND ADAPTERS AT BOTH ENDS OF ADAPTERS OF THE CATHETER. PER VISUAL INSPECTION NO ISSUES WERE DETECTED. ALSO, A LEAK TEST WAS CONDUCTED TO EVALUATE THE REPORTED ISSUE. THE TEST SHOWED THAT THE CATHETER DID NOT PRESENT ANY LEAKS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. 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
CUSTOMER REPORTS: THE PRODUCT IS LEAKING.