Description of Event or Problem · 0
WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. ACCORDING TO THE REPORTER, THE PATIENT WENT TO THE INTERVENTIONAL RADIOLOGY SUITE TO HAVE A HEMODIALYSIS CATHETER PLACED. THE CATHETER WAS PLACED SUCCESSFULLY. THE RED AND BLUE CAPS WERE PLACED AT THE END OF THE PORTS BY THE PROCEDURALIST. INTERVENTIONAL RADIOLOGY NURSING CONFIRMED THAT THE CAPS WERE IN PLACE. THIS WAS DOCUMENTED IN BOTH THE CENTRAL LINE CHECKLIST AND THE PROCEDURE REPORT. ON THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO THE HEMODIALYSIS UNIT TO HAVE A DIALYSIS SESSION. IT WAS FOUND THAT THE WHITE CAP HAD COME OFF OF THE RED CAP AT THE END OF THE LUMEN. THE CAPS WERE NOTICED TO BE OFF/MISSING ON (B)(6). THE CATHETER HAD BEEN IN PLACE FOR 1 DAY. THE LINE WAS THEN DEEMED TO BE POTENTIALLY CONTAMINATED AND UNABLE TO BE USED. THE PATIENT THEN RETURNED TO THE FLOOR, UNABLE TO COMPLETE THEIR DIALYSIS SESSION. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE LINE WAS FLUSHED, AND THE CAPS WERE IN PLACE AS INTENDED AT THE END OF THE PROCEDURE IN IR. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CAPS APPEARED INTACT PRIOR TO BEING PLACED ON THE CATHETER. THERE WAS NO LEAK AND NO ADDITIONAL ADAPTER WAS USED. THE LINE WAS DEEMED POTENTIALLY CONTAMINATED SOLELY DUE TO THE CAP DETACHMENT AND ASSUMED THAT THIS WAS A DEVICE DEFECT. THE PATIENT REQUIRED A SECOND PROCEDURE TO HAVE THE LINE REPLACED, TWO DAYS AFTER THE FIRST HEMODIALYSIS CATHETER WAS PLACED. THE ORIGINAL INTENDED PROCEDURE WAS FOR THE PATIENT TO HAVE A HEMODIALYSIS LINE PLACED AND TO RECEIVE A RUN OF HEMODIALYSIS. THIS EVENT CAUSED THE PATIENT TO MISS A DIALYSIS SESSION AND REQUIRED A SECOND PROCEDURE TO HAVE A NEW LINE PLACED. REPLACING THE CATHETER WAS THE REMEDIAL ACTION. THE PATIENT SUCCESSFULLY HAD A NEW CATHETER PLACED AND WAS ABLE TO RECEIVE HEMODIALYSIS AS PLANNED ON (B)(6). THERE WAS NO BLOOD LOSS. THERE WAS REPORTABLE PATIENT ¿HARM¿ FROM HAVING THE CATHETER REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).