Description of Event or Problem · 1
SHERWOOD MEDICAL, 1915 OLIVE ST, ST LOUIS, MO 63103-1642. TWO USED 18 FR SAMPLES WERE RETURNED, TOGETHER WITH THREE UNUSED CATHETER. TWO OF THE 18 FR UNUSED CATHETERS WERE FROM LOT #896338 AND THE ONE REMAINING WAS A 16FR SIZE, LOT #897362. THE TWO USED 18FR SAMPLES WERE IDENTIFIED AS COMING FROM LOT#894459 AND LOT #895179, RESPECTIVELY. THE SYMMETRY OF THE FIVE BALLOONS WERE CHECKED AFTER INFLATING THEM WITH WATER. THE BALLOON SYMMETRY MEASUREMENTS WERE FOUND TO BE ACCEPTABLE ON ALL FIVE SAMPLES. THE THREE UNUSED CATHETERS WERE CHECKED FOR PREMATURE DEFLATION AND PRUNING (RIDGES ON THE BALLOON) BY INFLATING THE BALLOONS WITH WATER AND IMMERSING IN A 38 DEGREE C WATERBATH FOR 24 HOURS. DURING (BEFORE AND AFTER) THE 24 HRS IMMERSION, THE CATHETER BALLOONS WERE ABLE TO BE INFLATED AND DEFLATED WITHOUT DIFFICULTY; NO LEAKAGE FROM THE BALLOONS OCCURRED. SOME RIDGING (PRUNING) OF THE BALLOONS WAS NOTED ON THESE CATHETERS, BUT EVEN SO THEY STILL FELL WITHIN ACCEPTABLE LIMITS. THE TWO USED COMPLAINT SAMPLES DISPLAYED WRINKLING OF THE BALLOONS, BUT LIKEWISE SATISFIED FRENCH SIZE REQUIREMENTS. BALLOON PLACEMENT AND LENGTH MEASUREMENTS FELL WITHIN THE SPECIFIC DRAWING TOLERANCES. THE TWO LUBRICATED JELLY SYRINGES WERE ALSO CHECKED TO SEE IF THE CAPS WERE HARD TO REMOVE. THE CAPS ON THESE SYRINGES WERE SOMEWHAT DIFFICULT TO REMOVE. SAMPLES WERE SENT TO THE MFG PLANT FOR THEIR REVIEW. ACCORDING TO OUR PLANT, THERE WAS NOTHING IN THE LOT HISTORY RECORDS INDICATIVE OF PREMATURE DEFLATION OR A BALLOON PRUNING PROBLEM. THE PLANT WAS UNABLE TO DUPLICATE THE PREMATURE DEFLATION REPORTED. THE LOT RECORDS FOR THE HARD-TO-REMOVE CAPS WERE REVIEWED. THE REMOVAL FORCES WERE EQUIVALENT TO OTHER LOTS PRODUCTS. THE CAPS ARE DESIGNED TO TWIST OFF RATHER THAN BE PULLED OFF. THE MFG PLANT HAS BEEN NOTIFIED OF THE DIFFICULTY EXPERIENCED IN REMOVING THE CAPS.