NOVAPLUS

Additional Manufacturer Narrative

THE MANUFACTURER, NSP TECH PTE LTD RECEIVED NOTIFICATION OF A SLICING MALFUNCTION REGARDING THE NOVAPLUS DEVICE VIA THE FDA MEDSUN NETWORK. UPON RECEIPT OF THE REPORT 2402140000-2026-8005, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS INITIATED. NO SYSTEMIC PROBLEM WAS FOUND. THE PHYSICAL DEVICE HAS BEEN SUCCESSFULLY RETURNED TO OUR ENGINEERING TEAM AND HAS UNDERGONE PHYSICAL, MECHANICAL, AND FUNCTIONAL ANALYSIS TO REPLICATE THE REPORTED FAILURE MODE. THE INVESTIGATION CARRIED OUT DETERMINED THAT THE ISSUE COULD BE CAUSED BY THE FORCE OF THE SPRING COMPONENT BEING ON THE RANGE OF BETWEEN LOW AND NOMINAL END OF THE SPECIFICATION AND THIS COULD HAVE LED TO A LOWER SLICING DEPTH OR CUTTING FORCE. WE HAVE IMMEDIATELY ARRANGED TO HAVE SPRING COMPONENT PRODUCED WITH FORCE OF RANGE BETWEEN NOMINAL AND HIGH END OF SPECIFICATION. TO DATE, THERE IS NO ABNORMALITY FOUND. WITH THE DHR AND THE DEVICE.

Description of Event or Problem

PRODUCT DID NOT SLICE AS EXPECTED. DID NOT PROVIDE A STANDARD SLICE, SO INFANTS WERE NOT ABLE TO PROVIDE ENOUGH BLOOD FOR THE SAMPLES NEEDED.