Description of Event or Problem · 1
BAXTER HEALTHCARE CORP. ROUTE 120 & WILSON RD, ROUND LAKE, IL 60073-0490. EVALULATION RESULTS. EIGHTEEEN UNUSED SUBCUTANEOUS ADMINISTRATION SETS OF THE REPORTED LOT NUMBER WERE RETURNED FOR EVALUATION. A PUSH TEST WAS PERFORMED ON THE 27 GAUGE SUBCUTANEOUS NEEDLE USING A FORCE GAUGE. THE PUSH FORCES RANGED FROM 0.14 TO 0.31 POUNDS. ALL OF THE NEEDLES BENT DOWNWARD AND REBOUNDED TO THEIR ORIGINAL BEND WHEN RELEASED. THE NEEDLES WERE VISUALLY INSPECTED AFTER THE PUSH TEST USING 10X MAGNIFICATION. NO CRACKS OR OTHER DEFECTS WERE OBSERVED. IN SUMMARY, NO ABNORMALITIES IN THE NEEDLES OF THE ADMINISTRATION SETS WERE FOUND. WITH THIS REPORT IT WAS COMMENTED THAT THE ABDOMINAL SITE WAS USED AND THIS AREA WAS FREE OF BELTS OR RESTRAINTS. IT IS NOT KNOWN IF OTHER FACTORS WERE INVOLVED. THERE IS NO STATEMENT IN THE PRODUCT LABELING REGARDING FREQUENCY OR SEVERITY WITH THIS ISSUE, NOR IS THERE ANY EXPECTED FREQUENCY OR SEVERITY OF OCCURRENCE WITH THIS ISSUE. A REVIEW OF OUR COMPLIANT DATABASE SHOWED FOUR OCCURRENCES IN 1995 AND ONE ADD'L OCCURENCE IN 1996 FOR BREAKAGE OF THE NEEDLE. THREE OF THESE PREVIOUS OCCURRENCES INVOLVED DISERTION OF THE DEVICE INTO THE LEG OR THIGH AREA OF THE PTS, WERE EXCESSIVE MANIPULATION CAN OCCUR.