RSDL

Description of Event or Problem

LEAKING PACKETS OF RSDL [DEVICE LEAKAGE] CASE NARRATIVE: ON 18-OCT-2022, A SPONTANEOUS REPORT WAS RECEIVED FROM A DISTRIBUTOR REGARDING "LEAKING PACKETS OF RSDL" (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME) (PT: DEVICE LEAKAGE); LOT NUMBER: 23005060. ON (B)(4) 2022, A QUANTITY OF (B)(4) CASES ((B)(4) PACKETS PER CASE) OF RSDL 42 ML (MN F5408ENG) WAS RECEIVED BY THE DISTRIBUTOR AND (B)(4) INDIVIDUAL PACKETS OF RSDL FROM SEVERAL DIFFERENT CASES WERE LEAKING. THE REPORTER ALSO NOTED THAT THEY "SHIPPED AT LEAST (B)(4) OF THESE CASES OUT." NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING PACKETS. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: THIS CASE REFERS TO LEAKING PACKETS OF RSDL (PT: DEVICE LEAKAGE) WHICH WAS RECEIVED BY A DISTRIBUTOR. 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.