RSDL

Description of Event or Problem

FOUND IN ONE CARTON ONE LEAKING POUCH (INCOMPLETE SEAL) [DEVICE LEAKAGE] FOUND IN ONE CARTON ONE LEAKING POUCH (INCOMPLETE SEAL) [PRODUCT CONTAINER SEAL ISSUE] CASE NARRATIVE: ON 10-NOV-2022, A SPONTANEOUS REPORT WAS RECEIVED FROM A DISTRIBUTOR WHO "FOUND IN ONE CARTON ONE LEAKING POUCH (INCOMPLETE SEAL)" (PT: DEVICE LEAKAGE AND PT: PRODUCT CONTAINER SEAL ISSUE) OF RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23005061, EXPIRY DATE: 31-JUL-2027). ON 10-NOV-2022, AFTER VISUAL INSPECTION OF THE 7 CARTONS RECEIVED, THE DISTRIBUTOR REPORTED THAT ONE POUCH WAS FOUND LEAKING IN ONE OF THE CARTONS OF RSDL AND DESCRIBED THIS AS AN INCOMPLETE SEAL. FURTHERMORE, THE REPORTER NOTED THAT SOME DECONTAMINATION LIQUID SPREAD IN THE CARTON AND MOST OF THE OTHER POUCHES IN THIS CARTON WERE SOILED. THIS CARTON WAS REFUSED AS MOST OF THE OTHER POUCHES WERE SOILED. THE REPORTER STATED THAT ALL POUCHES IN THE REMAINING 6 CARTONS WERE VISUALLY INSPECTED FOR SEAL INTEGRITY AND TRACES OF LIQUID AND NO ISSUES WERE IDENTIFIED AND THESE CARTONS WERE ACCEPTED. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING POUCH. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: IT WAS REPORTED THAT THE RSDL POUCH WAS NOT COMPLETELY SEALED (PT: PRODUCT CONTAINER SEAL ISSUE) AND FOUND LEAKING (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.