MC-RAN-8C

Description of Event or Problem

PER BIOGENNIX: "THE RANFAC DEVICE LOT NUMBER IS 50728 (MC-RAN-8C) FOR BOTH KITS THE CUSTOMER USED. THE HEALTHCARE PROFESSIONAL COMPLAINED THAT BOTH PRODUCTS BENT DURING INSERTION. HE USED 2 LOTS OF OUR PRODUCT WITH THE SAME LOT NUMBER OF RANFAC COMPONENT."

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO RANFAC FOR ANALYSIS. DOCUMENTS THAT WERE INVOLVED IN THIS COMPLAINT, SUCH AS THE DHR, IFU, AND RISK DOCUMENTATION, WERE REVIEWED, AND THERE WERE NO ANOMALIES WERE FOUND. BENT NEEDLES ARE CAUSED BY THE INCORRECT FORCE EXERTED ON THE NEEDLE DURING INSERTION OR THE STYLET IS PULLED PREMATURELY DURING INSERTION. THE USER DID NOT FOLLOW THE IFU, THEREFORE THE EVENT IS DUE TO USER ERROR. RANFAC DID NOT RECEIVE THE PRODUCT FOR RETURN, AS THE DEVICE WAS DISCARDED, THEREFORE INITIAL INVESTIGATION IS BASED ON THE DESCRIPTION OF THE EVENT. THE CUSTOMER WAS NOTIFIED THAT THE INCIDENT WAS A USER ERROR.