NIAGARA KIT 13.5F X 24CM (SHORT-TERM, DUAL-LUMEN)

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 COMPLAINT OF A DAMAGED INTRODUCER NEEDLE/CATHETER IS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. THE PRODUCTS RETURNED FOR EVALUATION WERE TWO 16 G IV INTRODUCER NEEDLES. THE RETURNED PRODUCT SAMPLES WERE EVALUATED AND THE TIP OF THE CATHETER WAS OBSERVED TO BE DAMAGED IN BOTH UNITS. THE FOLLOWING OBSERVATIONS WERE NOTED DURING THE SAMPLE EVALUATION: USAGE RESIDUE WAS SEEN ON THE SAMPLE. SLIGHT BUCKLING OF THE EDGES OF THE CATHETER WAS PRESENT THE SHAPE, LOCATION, AND EXTENT OF THE DAMAGE OBSERVED ON THE RETURNED SAMPLES SUGGEST THAT THE CATHETERS WERE MOST LIKELY DAMAGED DUE TO EXCESSIVE INSERTION FORCE, AN INADEQUATE SKIN NICK, AND/OR A STEEP INSERTION ANGLE. ADDITIONALLY, INSPECTION OF THE NEEDLE TIPS DID NOT FIND ANY DAMAGE OR DEFORMITIES TO THE BEVEL. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

Description of Event or Problem

IT WAS REPORTED THAT TWO CASES CONTINUED IN WHICH THE OUTER TUBE OF THE PUNCTURE NEEDLE WOUND UP DURING PUNCTURE AND THE BLOOD VESSEL COULD NOT BE SECURED. THERE WAS NO REPORTED PATIENT INJURY. (B)(6) 2024 - BOTH RETURNED SAMPLES EXHIBITED DAMAGE AT THE TIP OF THE CATHETER. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.