ARGYLE

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE UMBILICAL VEIN CATHETER (UVC) WAS PLACED AS THEY WERE UNABLE TO OBTAIN PERIPHERAL INTRAVENOUS (PIV) ACCESS. THE UVC WAS PLACED, AND INFANT TOLERATED THE PROCEDURE WELL. WHEN THE REGISTERED NURSE (RN) WENT TO HOOK UP FLUIDS TO THE UVC PRIMARY HUB, THE IV TUBING WOULD CONNECT, BUT NOT SCREW ON. IT JUST KEPT TURNING AND NOT SCREW ON TIGHTLY. THE RN TRIED TO SCREW THE IV FLUIDS ON TO THE SECONDARY LUMEN HUB AND THE IV FLUIDS WOULD ALSO NOT SCREW ON PROPERLY BUT WERE TIGHTER THAN THE PRIMARY LUMEN HUB. NEONATAL NURSE PRACTITIONER (NNP) CALLED TO THE BEDSIDE AND THE SITUATION WAS EXPLAINED. NNP STUDENT WHO PLACED THE UVC STATED THAT HE DIDN'T NOTICE ANY DIFFICULTY WHEN SCREWING ON A SYRINGE TO DRAW LABS AND VERIFY UVC PLACEMENT. UPON FURTHER INVESTIGATION, IT LOOKED LIKE THERE WERE "RIDGES" ON THE PRIMARY HUB THAT PREVENTED IV FLUIDS FROM BEING TIGHTENED PROPERLY. IT WAS DECIDED THAT THEY WOULD NOT USE THE PRIMARY HUB, AND IT WAS TAPED OFF, SO ALL OTHER STAFF KNEW NOT TO USE. AS FOR THE SECONDARY, A CLAVE WAS PLACED TO HELP MAKE THE CONNECTION TIGHTER, AND IV FLUIDS WERE BEING RAN THROUGH THE SECONDARY LUMEN. THERE WAS NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2404400070 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A FEW PICTURES WERE PROVIDED FOR ANALYSIS, AND THE REPORTED ISSUE WAS NOT OBSERVED DUE TO THE LOW-QUALITY IMAGES. A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED ISSUE. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, BASED ON THE PREVIOUS EVENTS REPORTED, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.