NIAGARA SLIM-CATH

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.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, A PHYSICIAN PERFORMED A RIGHT FEMORAL TEMPORARY CATHETER PLACEMENT PROCEDURE ON A PATIENT. DURING THE PROCEDURE, BLOOD AND AIR LEAKAGE WERE DETECTED FROM THE PUNCTURE NEEDLE; HOWEVER, THE PATIENT WAS NOT HARMED. THE NEEDLE WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE PUNCTURE WAS COMPLETED.