KIT IV START WITH IPA/PVP STERILE 100S

Description of Event or Problem

LOGISTICS CONDUCTED A RANDOM QUALITY CONTROL INSPECTION OF THE LSL STERILE IV START KIT, ITEM 3194, FROM LOT NUMBER 4D3101. THIS INSPECTION REVEALED THE SAME ISSUE REPORTED IN (B)(4) (WAS DISCOVERED THAT ALL THEIR KITS CONTAINS ALCOHOL SWABS DRY, THIS ISSUE HAS BEEN FOR YEARS BUT THE FIRST TIME REPORTED): THE ALCOHOL SWAB INCLUDED IN THE KIT APPEARED BLOATED (FULL OF AIR) AND WAS DRY TO THE TOUCH UPON OPENING. ADDITIONALLY, WE CONDUCTED THREE RANDOM QUALITY CONTROL SAMPLES OF IV START KIT 3194 FROM A DIFFERENT LOT NUMBER, 4H3083, WHICH CONFIRMED THAT ALL THESE KITS HAD AN ALCOHOL SWAB THAT WAS DRY AND FULL OF AIR. THE INVESTIGATION REVEALED THAT THE SAME ISSUE IS PRESENT IN ALL IV STERILE KITS, REGARDLESS OF THE VARIOUS LOT NUMBERS EXAMINED. THE PROBLEM MAY ORIGINATE DURING THE STERILIZATION PROCESS WHEN THE ALCOHOL EVAPORATES. PT CODE: 4580. DEVICE CODES: 1506, 2588. REF REPORTS: 5178722, 5178724, 5178725.