WARMER DRAPE

Additional Manufacturer Narrative

TWO SAMPLES WERE RECEIVED ON JUNE 9, 2017. BOTH DRAPES WERE OPENED AND OUT OF PACKAGES. ONE DRAPE FROM LOT D170941 AND ONE FROM LOT D170611 WERE RECEIVED. THERE APPEARED TO BE HOLES IN THE TOP SIDE OF THE DRAPES - ONE IN EACH OF THE CORNERS WHERE THE POCKET IS FORMED OVER THE FOAM PILLOW. ONE OF THE SAMPLES WAS EVALUATED AND NO WATER WAS FOUND UNDER THE DRAPE OR LEAKING DOWN THE DRAPE. WATER DID NOT LEAK INTO THE POCKET WHERE THE PILLOW SITS. THERE ARE SMALL PLEATS IN THE SEAL AROUND THE PILLOW BUT THEY ARE NOT HOLES OR CHANNELS FOR WATER TO FLOW THROUGH. THE SAMPLES WERE SENT TO THE MANUFACTURING FACILITY WHERE IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE ACTUAL DRAPE USED IN THE PROCEDURE WAS DISCARDED BY THE HOSPITAL AND WAS NOT AVAILABLE FOR REVIEW. THE DHR FOR LOT D170941 WAS REVIEWED AND IT WAS CONFIRMED THAT THIS LOT HAS (B)(4) UNITS THAT WERE MANUFACTURED ON COMBINED SHIFTS FROM 04/05/2017 TO 04/07/2017 AND THAT NO DEFECTS WERE REPORTED DURING THE QUALITY INSPECTIONS. THE MANUFACTURING PROCESS WAS REVIEWED AND IT WAS CONFIRMED THAT THE OPERATORS WERE PERFORMING THE MANUFACTURING PROCESS ACCORDING TO SPECIFICATION. AFTER THE ANALYSIS PERFORMED, EVALUATING THE PROCESS, AND REVIEWING THE SPECIFICATION AND THE SAMPLES RECEIVED FROM THE CUSTOMER IT WAS CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT IS RELATED TO USER PERCEPTION. NO ACTIONS ARE BEING TAKEN AT THIS TIME SINCE THE NON CONFORMANCE COULD NOT BE CONFIRMED.

Description of Event or Problem

FOLLOWING A 6 HOUR ROBOTIC UROLOGY PROCEDURE, AN END USER DISCOVERED A LOT OF FLUID UNDERNEATH THE DRAPE AND IN THE WARMER BASIN. UPON FURTHER INVESTIGATION OF THE DRAPE, THE END USER DISCOVERED TWO SMALL PUNCTURE HOLES ON THE TOP-SIDE OF THE DRAPE WHICH THEY BELIEVE CAUSED THE DRAPE TO LEAK FLUID. IN ADDITION, THEY ALSO NOTICED TWO SLITS ON THE UNDER-SIDE OF THE DRAPE THAT ARE ALSO OF CONCERN. FOLLOWING THE PROCEDURE, THE STAFF WENT TO INVESTIGATE THEIR REMAINING SUPPLY AND FOUND THE SAME ISSUES IN THE NEXT THREE UNITS THEY OPENED AND IT WASN'T UNTIL THE FOURTH UNIT THEY FOUND WHAT APPEARED TO BE AN ACCEPTABLE DRAPE WITHOUT THE ISSUES REPORTED. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.