NIAGARA KIT 20CM

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 CRACKED INTRODUCER NEEDLE IS INCONCLUSIVE DUE TO THE STATE OF THE RETURNED SAMPLE. ONE PHOTOGRAPH OF AN INTRODUCER NEEDLE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED THE DEVICE HELD IN HAND BY A CLINICIAN. NO VISIBLE SIGNS OF A BREAK, CRACK, OR LEAK IN THE DEVICE COULD BE DISCERNED FROM THE PHOTOGRAPH. NO ADDITIONAL DAMAGE OR USE RESIDUE WAS NOTED. INSPECTION OF THE RETURNED PHOTOGRAPH WAS INSUFFICIENT TO IDENTIFY THE ALLEGED ISSUE OR A ROOT CAUSE OF THE REPORTED ISSUE. THEREFORE, THIS COMPLAINT IS INCONCLUSIVE AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

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 IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE PORT AT THE NEEDLE TIP CRACKED. WHEN THE DEVICE WAS CONNECTED TO A SYRINGE UNDER NEGATIVE PRESSURE, LEAKAGE WAS DETECTED. THIS REPORT ADDRESSES ONE DEVICE.