MICRO-VOLUME EXTENSION SET

Additional Manufacturer Narrative

D4 UDI: AS THE LOT# IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP THREE LEAD CATHETER EXTENSION SET LEAKED. THE REPORTER STATED THAT THE "DRIP THAT WAS LEAKING WAS A PARALYTIC". IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED INCREASED SEDATION TO MAINTAIN STABILITY UNTIL THE LEAKAGE WAS IDENTIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE.