ARGYLE

Additional Manufacturer Narrative

SECTION B5 HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION. EMDR SECTION H6 HAS BEEN UPDATED TO INCLUDE HEALTH EFFECT - IMPACT CODE 4629 DEVICE REVISION OR REPLACEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE NURSE PRACTITIONER (NP) CHANGED THE MALPOSITIONED UMBILICAL VESSEL CATHETER (UVC). THE OLD CATHETER WAS REMOVED, AND A NEW CATHETER WOULD NOT PASS THROUGH LIVER TO IVC/ ATRIAL JUNCTION. THE CATHETER WAS RETRACTED TO LOW LYING AND SUTURED AS APPROXIMATELY 3CM. THE NP WAS FLUSHING/DRAWING FROM LINE AND NOTICED AIR BUBBLES. NP ATTEMPTED TO REMOVE THE LINE, AND THE CATHETER ¿SNAPPED¿ LEAVING APPROXIMATELY 3 CM OF CATHETER IN BABY WITH THE END NOT VISIBLE AT CORD STUMP. THERE WAS NO BLOOD LOSS REPORTED, STAT BABYGRAM WAS ORDERED AND SURGERY WAS CONSULTED. THE RADIOGRAPH DEMONSTRATED THAT THE CATHETER SEGMENT WAS BELOW THE LIVER, BUT NOT IN CORD STUMP. THE BABY MADE NIL PER OS (NPO) AND PERIPHERAL INTRAVENOUS LINE (PIV) X 2 WAS PLACED. THE BABY WAS AIR TRANSPORTED TO LEVINE CHILDREN¿S HOSPITAL IN CHARLOTTE, NORTH CAROLINA FOR PEDIATRIC INTERVENTIONAL SURGERY TO RETRIEVE RETAINED PIECE OF CATHETER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE INITIALLY MALPOSITIONED UMBILICAL VESSEL CATHETER WAS ALSO (B)(4) UMBILICAL CATHETER SNGL LUMEN 3.5FR AND THE SAME BATCH NUMBER 2431800139. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE CORRECT WEIGHT OF THE PATIENT WAS 0.94 KG.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE NURSE PRACTITIONER (NP) CHANGED THE MALPOSITIONED UMBILICAL VESSEL CATHETER (UVC). THE OLD CATHETER WAS REMOVED, AND A NEW CATHETER WOULD NOT PASS THROUGH LIVER TO IVC/ATRIAL JUNCTION. THE CATHETER WAS RETRACTED TO LOW LYING AND SUTURED AS APPROXIMATELY 3 CM. THE NP WAS FLUSHING/DRAWING FROM LINE AND NOTICED AIR BUBBLES. NP ATTEMPTED TO REMOVE THE LINE, AND THE CATHETER "SNAPPED" LEAVING APPROXIMATELY 3 CM OF CATHETER IN BABY WITH THE END NOT VISIBLE AT CORD STUMP. THERE WAS NO BLOOD LOSS REPORTED, STAT BABYGRAM WAS ORDERED AND SURGERY WAS CONSULTED. THE RADIOGRAPH DEMONSTRATED THAT THE CATHETER SEGMENT WAS BELOW THE LIVER, BUT NOT IN CORD STUMP. THE BABY MADE NIL PER OS (NPO) AND PERIPHERAL INTRAVENOUS LINE (PIV) X 2 WAS PLACED. THE BABY WAS AIR TRANSPORTED TO (B)(6) HOSPITAL IN (B)(6) FOR PEDIATRIC INTERVENTIONAL SURGERY TO RETRIEVE RETAINED PIECE OF CATHETER.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Additional Manufacturer Narrative

A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT 2431800139 AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO DEVICES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE ARE UNABLE TO ASSOCIATE THIS REPORTED ISSUE WITH AN OPEN CAPA DUE TO NO PHOTO OR SAMPLE RECEIVED FOR EVALUATION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.