ARGYLE

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN UMBILICAL CATHETER THAT WAS REMOVED FROM A PATIENT AFTER A FEW DAYS USE BECAUSE THE CONNECTION WOULD NOT STAY SECURELY ATTACHED TO THE IV FLUID LINES. PER CUSTOMER, THE TEETH WERE WORN DOWN OR CHIPPED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CONNECTION HUB HAS TWO TEETH AND CAUSED CONNECTION ISSUE. THERE WAS NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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, 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.