ARTHROMATIC/UROMATIC

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWED A RED PARTICLE INSIDE THE DRIP CHAMBER WHICH APPEARED TO BE FROM THE RED CAP ON THE SPIKE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A RED FOREIGN OBJECT WAS IDENTIFIED IN THE DRIP CHAMBER OF A Y-TYPE TUR/BLADDER IRRIGATION SET. THIS WAS OBSERVED DURING SET UP. THE FOREIGN OBJECT WAS DESCRIBED AS A "RED FLAKE" WHICH APPEARED TO HAVE ORIGINATED FROM THE RED CAP OF THE BAG SPIKE, AS A CORRESPONDING GROOVE WAS NOTED TO BE MISSING FROM THE CAP AFTER THE REMOVAL. THE CAP HAD NOT BEEN REMOVED AT THE TIME THE RED FLAKE WAS INITIALLY OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.