UMBILICAL CATHETER

Additional Manufacturer Narrative

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

Description of Event or Problem

UMBILICAL CATHETER FOUND LEAKING.

Additional Manufacturer Narrative

THE MALFUNCTIONING DEVICES 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.