UMBILICAL CATHETER TRIPLE LUMEN 5FR

Additional Manufacturer Narrative

THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. ONE USED CATHETER AND FEW PICTURES WERE RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION, THE CATHETER SHOWED SIGNS OF USE (SUCH AS RESIDUES OF BLOOD) AND WAS IDENTIFIED THAT THE CATHETER WAS BROKEN ON ITS TUBE. ADDITIONALLY, DURING THE PHYSICAL/ FUNCTIONAL EVALUATION, THE RETURNED SAMPLE WAS SUBMITTED TO UNDERWATER TEST AND A LEAK WAS IDENTIFIED IN THE SECTION OF THE TUBE NEAR THE NUMBER 10 MARKING WHEN THE PRIMARY EXTENSION WAS CONNECTED AND TESTED, THE OTHER TWO EXTENSIONS (SECONDARY AND TERTIARY) DID NOT PRESENT ANY DEVIATIONS. THEREFORE, THE REPORTED ISSUE IS CONFIRMED. THE CUSTOMER STATED THAT ¿A LEAK WAS DISCOVERED, WHEN THE CATHETER WAS USED ON THE PATIENT, AFTER INSERTION¿. BASED ON THE CUSTOMER PROVIDED INFORMATION, THE LEAKING WAS NOTICED AFTER INSERTION OF THE CATHETER. THE DEVICE WAS IN GOOD CONDITION PRIOR TO USE, WHEN FLUSHING AND PLACING IT, AND NOT CORRECTLY FOLLOWING THE INSTRUCTIONS FOR USE/ INDICATED USE COULD CONTRIBUTE TO THE CATHETER DAMAGE DURING USE. DURING INVESTIGATION, NO MANUFACTURING RELATED POTENTIAL CAUSE WAS IDENTIFIED. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT A 39.3 WEEK GESTATION INFANT WAS ADMITTED IN NEWBORN INTENSIVE CARE UNIT (NICU) FOR MECONIUM ASPIRATION WITH RESPIRATORY SYMPTOMS (MAS) AND WAS EMERGENTLY INTUBATED. A TRIPLE LUMEN CATHETER WAS PLACED IN THE INFANT BY A NEONATAL NURSE PRACTITIONER (NNP) AND WAS NOTED TO BE LEAKING CONSISTENTLY IN LINE (HOLE/CRACK IN IT). THE LINE WAS IMMEDIATELY REMOVED, AND ANOTHER LINE WAS PLACED. PER CUSTOMER, THERE WAS NO INJURY OR ADVERSE REACTION OCCURRED TO THE PATIENT INVOLVED.