MalfunctionFOS
VYGON UMBILICAL CATHETER
Received Jul 14, 2017 · Event occurred Nov 28, 2016
Report 2245270-2016-00092 · MDR key 6714980
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ORIGINAL DATE OF THIS MDR REPORT WAS 12/20/2016.
Description of Event or Problem
UC STOPCOCK'S DEAD END CAP LEAKED DIRECTLY FROM RECESS @ TOP OF CAP X2 SEPARATE INSTANCES. SUSPECT CRACK "STEM" UNDERSIDE OF CAP. FIRST EVENT 1270.03 (3.5 FR. SL) AND SECOND 1270.05 (5.0 FR. SL) FILED SEPARATELY. STAFF DIDN'T RETAIN EITHER EXAMPLE FOR INSPECTION. THE PACKAGING OF BOTH UCS HAD BEEN DISCARDED PRIOR TO LEAKS IDENTIFIED SO SPECIFIC LOT NUMBERS WERE IDENTIFIED. STAFF DOCUMENTED LOT #S OF INVENTORY REMAINING SOON AFTER THE EVENTS.