RSDL

Description of Event or Problem

LEAKING PACKETS OF 21 ML RSDL [DEVICE LEAKAGE] MISALIGNMENT WHERE THE PACKET IS SEALED TOGETHER ALONG THE TOP EDGE [PRODUCT PACKAGING ISSUE]. CASE NARRATIVE: ON 25-JAN-2023, A SPONTANEOUS REPORT WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A DISTRIBUTOR WHICH RECEIVED LEAKING PACKETS OF 21 ML RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME) (PT: DEVICE LEAKAGE) AND DAMAGED PACKETS DESCRIBED AS "A MISALIGNMENT WHERE THE PACKET IS SEALED TOGETHER ALONG THE TOP EDGE" (PT: PRODUCT PACKAGING ISSUE); LOT NUMBER: 23005180. IT WAS REPORTED THAT THE DISTRIBUTOR RECEIVED A TOTAL OF 31,300 PACKETS OF RSDL OUT OF WHICH 19 PACKETS WERE FOUND TO BE LEAKING AND WERE DISPOSED OF IN THE TRASH; 78 PACKETS WERE DAMAGED BUT WERE RETAINED. IN TOTAL, 97 PACKETS WERE UNUSABLE. REPORTEDLY, THE PACKAGING WAS CONSISTENTLY TROUBLESOME AT THE NOTCHED POINTS AND THERE WAS MISALIGNMENT ALONG THE TOP EDGE OF THE PACKET WHERE IT WAS SEALED TOGETHER. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING PACKET. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: IT WAS REPORTED THAT PACKETS OF RSDL WERE FOUND LEAKING (PT: DEVICE LEAKAGE) AND SOME PACKETS APPEARED TO HAVE A MISALIGNMENT WHERE THE PACKET IS SEALED TOGETHER ALONG THE TOP EDGE (PT: PRODUCT PACKAGING ISSUE). RSDL IS INTENDED TO BE USED FOR THE DECONTAMINATION OF SKIN EXPOSED TO CHEMICAL WARFARE AGENTS (CWA) AND T-2 TOXIN. AN RSDL PACKET THAT LEAKS COULD MAKE THE COMPOSITION OF THE PACKET DRY OUT OR LESS RSDL AVAILABLE AND THAT MAY AFFECT THE EFFICACY OF THE DEVICE. IN A SITUATION WHEREBY AN INDIVIDUAL IS EXPOSED TO CWA AND NEEDS IMMEDIATE DECONTAMINATION WITH RSDL, THERE EXISTS THE POSSIBILITY OF A LACK OF EFFICACY OF THE DEVICE WHICH WILL MAKE THE PERSON VULNERABLE TO HEALTH HAZARDS FROM THE CWA OR T-2 TOXIN. WHILE PACKET LEAKS HAVE BEEN KNOWN TO OCCUR, A RISK/BENEFIT POSITION POINTS TO A REDUCTION IN RISK FROM A CHEMICAL WARFARE ATTACK EVEN IF USING A LEAKING AND/OR DELAMINATED PACKET OF RSDL.