RSDL

Description of Event or Problem

RSDL LEAKY PACKETS [DEVICE LEAKAGE] CASE NARRATIVE: THIS INITIAL SPONTANEOUS CASE REPORT WAS RECEIVED ON 23APR2025 FROM NON-HEALTH PROFESSIONAL (CUSTOMER) REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23004362, 23004357, 23002388, 23003020). THE PRODUCT COMPLAINT WAS REPORTED REGARDING "RSDL LEAKY PACKETS" (PT: DEVICE LEAKAGE) A PRODUCT COMPLAINT WAS REPORTED ABOUT RSDL LEAKY PACKETS FROM LOT NUMBERS 23004362, 23004357, 23002388, AND 23003020. DURING ROUTINE CHECKS AND INSPECTIONS, STOCK DEFECTS AND LEAKING PACKETS WERE FOUND IN SOME CARTONS. THESE LOTS WERE MANUFACTURED IN 2019, 2020, AND 2021, BEFORE THE CORRECTIVE ACTIONS IMPLEMENTED IN RESPONSE TO THE 2022 RSDL RECALL. TWO OF THE LOTS (23003020 AND 23002388) WERE ALREADY EXPIRED. LEAKY PACKETS WERE CONSIDERED CRITICAL FAILURES (DEVICE FAILURE), BUT THEY WERE EASY TO DETECT AND WOULD NOT BE USED. THE COMPLAINT WAS CLASSIFIED AS CRITICAL. FURTHER IT WAS REQUESTED TO RETURN OF THE LEAKY PRODUCT AND THE ORIGINAL SHIPPING BOXES FOR ANALYSIS, AS WELL AS INFORMATION ON STORAGE TEMPERATURE AND CONFIRMATION OF ANY DAMAGE TO THE SHIPPING CONTAINER DURING RECEIPT OR STORAGE. IT WAS CONFIRMED THAT THERE WAS NO REMAINING PRODUCT FROM THE AFFECTED LOTS WAS IN INVENTORY. THE OUTCOME OF THE REPORTED EVENT WAS NOT APPLICABLE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENT WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: THIS CASE REPORT WAS RECEIVED ON 23APR2025 FROM A NON-HEALTH PROFESSIONAL (CUSTOMER) REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME). A PRODUCT COMPLAINT WAS REPORTED REGARDING THE "RSDL LEAKY PACKETS" (DEVICE LEAKAGE) FROM LOT NUMBERS 23004362, 23004357, 23002388, AND 23003020. THE EVENT OF DEVICE LEAKAGE IS CONSIDERED AS SERIOUS (OTHER- MALFUNCTION). CONSIDERING THE LIMITED INFORMATION, THE CAUSALITY FOR THE EVENT OF DEVICE LEAKAGE HAS BEEN ASSESSED AS NOT RELATED TO RSDL. RSDL IS USED TO REMOVE OR NEUTRALIZE CHEMICAL AGENT OR T2 TOXIN SKIN EXPOSURE. ALTHOUGH THERE IS NO PATIENT EXPOSURE AND NO MEDICAL ADVERSE EVENT REPORTED IN THIS CASE, PACKAGE LEAKAGE MAY CAUSE REDUCED EFFICACY OF RSDL DUE TO DECREASED VOLUME OR DEGRADATION OF THE PRODUCT. IN WHICH CASE, USE OF THE LEAKING PACKAGE MAY POTENTIALLY LED TO SERIOUS INJURY OR DEATH OF THE PATIENT DUE TO CONTINUED EXPOSURE TO THE OFFENDING CHEMICAL AGENT. CASE COMMENTS: NA.