MAGELLAN

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD A NEEDLE STICK REPORTED AND THE CLAIM WAS THAT THE SAFETY MECHANISM DID NOT WORK CORRECTLY BUT UNFORTUNATELY THE ACTUAL PRODUCT AND PACKAGING WAS NOT RETAINED AND THE LOT NUMBER COULD NOT BE VERIFIED. ON (B)(6) 2026 THE CUSTOMER PROVIDED ADDITIONAL DETAILS STATING THAT THE INCIDENT OCCURRED AFTER PATIENT USE THEREFORE IT WAS A DIRTY NEEDLE STICK. A BLOOD DRAW WAS COMPLETED HOWEVER THE RESULTS ARE UNKNOWN. IT IS ALSO UNKNOWN IF THERE WAS AN AUDIBLE CLICK WHEN ATTEMPTING TO ACTIVATE THE SAFETY SHIELD. NO FURTHER DETAILS WERE PROVIDED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE SPECIFIC MANUFACTURING AND INSPECTION RECORDS WAS NOT POSSIBLE. HOWEVER, ALL PRODUCT LOTS ARE REQUIRED TO MEET ESTABLISHED ACCEPTANCE CRITERIA AND MUST SUCCESSFULLY PASS DEFINED VISUAL AND FUNCTIONAL INSPECTIONS PRIOR TO RELEASE. THERE WERE NO DEVICES OR PHOTOS RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE AND PREVENTATIVE ACTIONS REQUIRED AT THIS TIME HOWEVER WE WILL CONTINUE TO MONITOR AND TAKE ACTIONS, AS APPLICABLE.