Model Number 1272.14 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
Bacterial Infection (1735); Patient Problem/Medical Problem (2688)
|
Event Date 10/04/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Although we do not know if the failed device will be returned to vygon, the details of the complaint will be examined as part of the complaint investigation.This investigation is currently in process and the results will be forwarded to fda within 30 days of its conclusion via follow-up mdr.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.No other complaint has been registered on this batch.
|
|
Event Description
|
After 3 days , a leakage were noticed at the junction of both catheter's lumen.A serious deterioration of the state of health with a bacteremia was reported.The actual state of health of the patient is unknown.
|
|
Manufacturer Narrative
|
The root cause of this event cannot be defined.As no device was returned for investigation.It is seems not due to a defect of our device.All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process.No other complaint was registered for this batch.
|
|
Event Description
|
After 3 days , a leakage were noticed at the junction of both catheter's lumen.A serious deterioration of the state of health with a bacteremia was reported.The actual state of health of the patient is unknown.
|
|
Search Alerts/Recalls
|