MEDEX MICRO BORE EXTENSION SET W/ FILTER

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING LEAKED AT THE FILTER OR REQUIRED EXCESS PRESSURE TO PRIME/INFUSE FLUID. THIS OCCURRED DURING PATIENT INFUSION, BUT THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

D4. LOT NUMBER, EXPIRATION DATE, UDI, AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. E.4. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5150083. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

DEVICE EVALUATION: NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.