BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS LEAKING ISSUE WITH NASOGASTRIC TUBE 0046160. GIVEN THE POTENTIAL PATIENT SAFETY CONCERNS, WE WOULD APPRECIATE THE PROMPT REVIEW AND GUIDANCE ADDITIONALLY, ARE THERE ANY RECALLS OR KNOWN MANUFACTURING ISSUES AFFECTING CERTAIN PRODUCTION LOTS THAT THEY MAY NOT BE AWARE OF. PER REQUEST RESPONSE, REFLUX OF GASTRIC CONTENTS INTO THE BLUE VENT LUMEN INDICATES THAT THE SUCTION LUMEN IS OBSTRUCTED, OR SUCTION IS TOO LOW. ROUTINELY CHECK FOR REFLUX IN THE BLUE VENT LUMEN AND CLEAR AS PER APPLICABLE DIRECTIONS. FAILURE TO CLEAR THE OBSTRUCTION MAY CAUSE GAS AND FLUID BUILDUP IN STOMACH, ASPIRATION OF GASTRIC CONTENTS, ASPIRATION PNEUMONIA AND OTHER COMPLICATIONS. DO NOT INJECT FLUID THROUGH THE PREVENT FILTER AS THIS MAY RESULT IN BLOCKAGE AND LEAKAGE OF FILTER. KEEP BLUE VENT LUMEN ABOVE THE LEVEL OF THE PATIENT'S STOMACH TO PREVENT REFLUX OF STOMACH FLUIDS INTO THE BLUE LUMEN. THE PRODUCT NUMBERS FOR THESE TUBES INCLUDE THE FOLLOWING: 0042100, 0042120, 0042140, 0042160, 0042180, 0046100, 0046120, 0046140, 0046160, 0046180. FOR THE LATEST INFORMATION, ALWAYS CHECK THE INSTRUCTIONS FOR USE THAT COMES PACKAGED WITH THE PRODUCT. CONSUMERS SEEKING ADDITIONAL INFORMATION MAY CONSULT THEIR HEALTHCARE PROVIDERS. PER THE ATTACHED IFU, IF LOPEZ VALVE WAS USED, RETURN VALVE TO POSITION ONE WHEN COMPLETE TO AVOID LEAKAGE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.