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 PATIENT HAD THIS LINE PLACED IN THE RT IJ. AFTER THE LINE WAS LOCKED, THE PROVIDER NOTED THAT IT WAS BACK FILLING WITH BLOOD. CONCERNED FOR A LEAK, THE PROVIDER REPLACED THE LINE INTRAPROCEDURAL PRIOR TO SUTURING IN PLACE. THE NEW LINE APPEARED TO BE INTACT. DURING THE PATIENT'S TREATMENT AFTER THE PLACEMENT, WE WERE CONTACTED BY THE TEAM BECAUSE THE LINE WAS LEAKING. THE PATIENT WAS AGAIN BROUGHT TO THE IR DEPARTMENT AND A 3RD LINE WAS PLACED FROM A DIFFERENT LOT NUMBER AND WAS SUCCESSFUL. DELAY IN TREATMENT PLAN BY APPROXIMATELY 24HOURS. OVERNIGHT STAY WAS REQUIRED TO ENSURE TIMING OF TREATMENT TO PREVENT A 3 MONTH DELAY FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

Additional Manufacturer Narrative

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 COMPLAINT OF LEAKING CATHETERS IS CONFIRMED AND WAS DETERMINED TO BE USE-RELATED. TWO 13 FR D/L DUOGLIDE DIALYSIS CATHETERS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE RETURNED CATHETERS SHOWED ABUNDANT BLOOD RESIDUES ALONG EACH DEVICE. EACH LUMEN WAS CLAMPED AT THE DISTAL END OF THE EXTENSION TUBING TO FUNCTIONALLY TEST THE PROXIMAL ENDS OF THE EXTENSION TUBING FOR LEAKS. A FUNCTIONAL TEST OF PRESSURIZING THE EXTENSION TUBING WITH WATER USING A 12 ML SYRINGE REVEALED THE BLUE LUMEN FOR EACH CATHETER LEAKED ALONG THE EXTENSION TUBING. A MICROSCOPIC OBSERVATION REVEALED TWO SMALL, OPPOSITE SPLITS IN THE BLUE LUMEN EXTENSION TUBING FOR EACH CATHETER. THE SPLIT CHARACTERISTICS INCLUDED SHARPLY FORMED FRACTURE EDGES THAT APPEARED TO FOLD INTO THE TUBING, AND UNEVEN FRACTURE SURFACES WITH SOME SECTIONS APPEARING SMOOTH, WHILE OTHER SECTIONS APPEARED MORE GRANULAR. THE SPLIT CHARACTERISTICS WERE OBSERVED UNDER A MICROSCOPE TO REVEAL DAMAGE CAUSED BY THE EXTENSION TUBING ENCOUNTERING AN INSTRUMENT. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.