UMBILICAL CATHETER
Received Jul 31, 2024 · Event occurred Sep 19, 2024
Report 2245270-2024-00068 · MDR key 19877042
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
3 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
UMBILICAL CATHETER FOUND LEAKING.
Additional Manufacturer Narrative
THE MALFUNCTIONING DEVICE WILL BE RETURNED TO THE MANUFACTURER AND UPON RECEIPT, AN INVESTIGATION WILL BE CONDUCTED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
Description of Event or Problem
UMBILICAL CATHETER FOUND LEAKING.
Additional Manufacturer Narrative
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