RSDL

Description of Event or Problem

SEALS ON TWO OF THE POUCHES OF RSDL DID NOT TAKE AND LEAKED PRODUCT [DEVICE LEAKAGE] SEALS ON TWO OF THE POUCHES OF RSDL DID NOT TAKE AND LEAKED PRODUCT [PRODUCT CONTAINER SEAL ISSUE] CASE NARRATIVE: ON (B)(6) 2022, A SPONTANEOUS REPORT WAS RECEIVED FROM A HEALTHCARE FACILITY/HEALTH CARE PROFESSIONAL REGARDING THE SEALS ON TWO POUCHES OF RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME) WHICH DID NOT TAKE AND LEAKED PRODUCT (PT: DEVICE LEAKAGE AND PT: PRODUCT CONTAINER SEAL ISSUE); LOT NUMBER: 23005062. UPON OPENING THE BOX CONTAINING THE RSDL POUCHES, THE REPORTER NOTICED SEALS ON TWO OF THE POUCHES OF RSDL (MN F5402) "DID NOT TAKE AND LEAKED THE PRODUCT." NO ADVERSE EVENTS WERE REPORTED RELATED TO THE LEAKING POUCHES. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: IT WAS REPORTED THAT THE SEALS ON TWO POUCHES OF RSDL DID NOT TAKE AND LEAKED THE PRODUCT (PT: DEVICE LEAKAGE, PT: PRODUCT CONTAINER SEAL 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.