RSDL

Description of Event or Problem

LEAKING POUCH OF RSDL [DEVICE LEAKAGE] CASE NARRATIVE: ON (B)(6) 2022, A SPONTANEOUS REPORT WAS RECEIVED FROM A DISTRIBUTOR REGARDING A LEAKING POUCH OF RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME) (PT: DEVICE LEAKAGE); LOT NUMBER 23005194. ON (B)(6) 2022, THE DISTRIBUTOR RECEIVED 7 CARTONS OF RSDL (BATCH 23005194). ON (B)(6) 2022, AFTER VISUAL INSPECTION OF THE 7 CARTONS RECEIVED, THE DISTRIBUTOR REPORTED THAT ONE OF THE 7 CARTONS CONTAINED A LEAKING POUCH. THE OPENING IN THE LEAKING POUCH WAS DESCRIBED AS "RATHER WIDE AND THE OTHER PACKETS FROM THE CARTON SOILED". THE REMAINING 6 CARTONS WERE OPENED AND SHOWED NO SIGN OF LEAKAGE. THE DISTRIBUTOR NOTED THAT ALL STOCK RECEIVED WAS QUARANTINED. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING POUCH. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED 7 CARTONS OF RSDL AND ONE OF THE CARTONS CONTAINED A LEAKING POUCH OF RSDL (PT: DEVICE LEAKAGE). 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.