NIAGARA

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 LEAK FROM INTRODUCER NEEDLE HUB IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE VIDEO OF A 18 GA INTRODUCER NEEDLE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE VIDEO SHOWED A LUER SLIP SYRINGE WITH CLEAR LIQUID ATTACHED TO THE HUB OF AN INTRODUCER NEEDLE. AS THE LIQUID WAS FLUSHED THROUGH THE NEEDLE, A LEAK WAS OBSERVED LIKELY DUE TO A CRACK IN THE NEEDLE HUB. NO DETAILS OF THE LEAK FROM IN THE RETURNED VIDEO COULD BE DISCERNED. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED VIDEO OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE, THE INTRODUCER NEEDLE EXHIBITED FLUID LEAKAGE AND DREW IN AIR DURING USE. AN ADDITIONAL NEW CATHETER HAD TO BE USED. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.