RSDL

Additional Manufacturer Narrative

DEVIATION-005822 HAS BEEN ISSUED, FOLLOW UP INFORMATION WILL INCLUDE RESULTS OF INVESTIGATIONS.

Description of Event or Problem

LEAKING PACKETS [DEVICE LEAKAGE]. CASE NARRATIVE: ON 13-FEB-2023, A SPONTANEOUS REPORT WAS RECEIVED FROM A THIRD PARTY DISTRIBUTOR REGARDING "LEAKING PACKETS" (PT: DEVICE LEAKAGE) OF RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23004910). IT WAS REPORTED THAT THE DISTRIBUTOR SHIPPED 6 CASES OF 42 ML ACTIVE RSDL TO THE DEPARTMENT OF DEFENSE (DOD)/DEPARTMENT OF SAFETY FOR UKRAINE RESPONSE. IN THE UKRAINE, ONE OF THE PACKETS IN ONE OF THE SHIPPED CASES WAS FOUND LEAKING. THE OUTCOME OF THIS REPORT IS NOT APPLICABLE. AT THE TIME OF THIS REPORT, THE LEAKING PACKET WAS STILL IN POSSESSION OF THE DOD. THE ACTION TAKEN WITH RSDL IS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: RSDL IS USED AS AN EXPOSURE TO TOXIC AGENT. CONSIDERING THE CASE INFORMATION, THE SAFETY RISK DUE TO CONTAMINATION WOULD BE MINIMUM. DUE TO DEHYDRATION AND LOW CONCENTRATION AS IT IS DEGRADABLE, AN RSDL LOTION THAT HAS LEAKED FROM THE PACKET MAY NOT BE AS EFFECTIVE AS INTENDED AND COULD MAKE THE EXPOSED INDIVIDUAL VULNERABLE TO HEALTH HAZARDS FROM THE CHEMICAL AGENT EXPOSURE. UNNECESSARY EXPOSURE TO THE NON-OPENED PACKETS THAT HAVE BEEN CONTAMINATED BY THE LOTION FROM THE LEAKED PACKETS COULD ALSO RESULT IN UNINTENTIONAL PROLONGED SKIN, EYES, AND MUCOUS MEMBRANE EXPOSURE TO THE MILITARY PERSONNEL AS WELL AS UNSUSPECTING HANDLERS OF THE SUBJECT RSDL KITS. EXPOSURE TO THE PRODUCT MAY LEAD TO SERIOUS INJURY AND/OR DEATH ALTHOUGH INJURIES OR DEATHS RELATED TO LEAKING PACKAGES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

DEVIATION-005822 HAS BEEN ISSUED, FOLLOW UP INFORMATION WILL INCLUDE RESULTS OF INVESTIGATIONS. 0.

Description of Event or Problem

LEAKING PACKETS [DEVICE LEAKAGE]. CASE NARRATIVE: ON (B)(6) 2023, A SPONTANEOUS REPORT WAS RECEIVED FROM A THIRD PARTY DISTRIBUTOR REGARDING "LEAKING PACKETS" (PT: DEVICE LEAKAGE) OF RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23004910). IT WAS REPORTED THAT THE DISTRIBUTOR SHIPPED (B)(4). IN THE (B)(6), ONE OF THE PACKETS IN ONE OF THE SHIPPED CASES WAS FOUND LEAKING. AT THE TIME OF THIS REPORT, THE LEAKING PACKET WAS STILL IN THE POSSESSION OF THE DOD/DOS FOR UKRAINE. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING PACKET. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: 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 IF USING A LEAKING AND/OR DELAMINATED PACKET OF RSDL.