DUOGLIDE

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS.

Description of Event or Problem

IT WAS REPORTED THE CLINICIAN NOTICED THAT AFTER THE VENOUS SIDE WAS FLUSHED AND CLAMPED, THE CATHETER STARTED TO BACK FILL. THE CLINICIAN THEN ASPIRATED, FLUSHED WITH SALINE, RE-FLUSHED WITH HEPARIN AND RE-CLAMPED THE CATHETER. AFTER ALL OF THAT, THE CLINICIAN NOTICED THAT THE CATHETER WAS STILL BACKFILLING. LATER IT WAS NOTED THAT SOME SALINE WAS ON THE PATIENT SHIRT, AND THAT LOOKED AS IF IT HAD LEAKED AND CAUSED THEM TO INSPECT THE LINE CLOSER. ON CLOSER INSPECTION, THE VENOUS LUMEN HAD SMALL HOLE THAT THEY COULD SEE LEAKING BLOOD. NO INJURIES OR SERIOUS EVENT  RESULTED DUE TO THIS INCIDENT.