RSDL

Description of Event or Problem

BOXED HAD A LEAKAGE [DEVICE LEAKAGE]. IT APPEARED THAT ONLY ONE PACKET HAD A SLIGHT DISCOLORATION [PRODUCT COLOUR ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS CASE REPORT WAS RECEIVED ON 17-JUN-2024 FROM OTHER HEALTH PROFESSIONAL REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23005929). IT WAS REPORTED THAT RSDL "BOXED HAD A LEAKAGE" (PT: DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PT: PRODUCT COLOUR ISSUE). THE PRODUCT COMPLAINT WAS REPORTED REGARDING THE RDSL 42 ML (MATERIAL F5410ENG). THE CUSTOMER NOTICED THAT ON "OF THE BOXED HAD A LEAKAGE, AS IT LOOKED ON THE OUTSIDE, AND FOUND ONLY ONE WITH A SLIGHT DISCOLORATION OF THE PACKAGE". THE CUSTOMER HAD CONFIRMED AFTER INSPECTING THE BOX AND PACKETS WITHIN, THAT ONLY ONE PACKET APPEARED TO HAVE A SLIGHT DISCOLORATION. THIS COMPLAINT WAS DOCUMENTED UNDER (B)(4) AND EMG2024-696 AND AN INVESTIGATION WAS INITIATED. THE OUTCOME OF THE REPORTED EVENTS WAS NOT APPLICABLE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENTS WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED ON 08-JUL-2024 FROM OTHER HEALTH PROFESSIONAL IN RESPONSE TO RAISED QUERY. IT WAS CONFIRMED THAT RSDL POUCH WAS NOT USED ON ANYTHING/ANYONE AS REPORTER NOTICED THE LEAKAGE ON THE CARDBOARD PACKAGING MATERIAL. AFTER THAT, REPORTER PUT THE CASE ASIDE. FURTHER, THE REPORTER NOTICED THAT 20 GRAM DIFFERENCE IN THE DAMAGED RSDL POUCH. COMPANY COMMENT: THIS CASE IS REGARDING THE RSDL 42 ML (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME). A CUSTOMER NOTICED THAT RSDL "BOXED HAD A LEAKAGE" (DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PRODUCT COLOUR ISSUE). FURTHER INFORMATION REGARDING THE EVENT WAS LIMITED. THE CAUSALITY OF PRODUCT LEAKAGE AND PRODUCT COLOUR ISSUE 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 AND/OR DEGRADATION OF THE PRODUCT. IN WHICH CASE, USE OF THE LEAKING PACKAGE MAY POTENTIALLY LEAD TO SERIOUS INJURY OR DEATH OF THE USER DUE TO CONTINUED EXPOSURE TO THE OFFENDING CHEMICAL AGENT. THAT BEING SAID, THIS CASE WILL BE CONSIDERED SERIOUS AS PER MEDICAL ASSESSMENT.

Description of Event or Problem

BOXED HAD A LEAKAGE [DEVICE LEAKAGE] IT APPEARED THAT ONLY ONE PACKET HAD A SLIGHT DISCOLORATION [PRODUCT COLOUR ISSUE] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS CASE REPORT WAS RECEIVED ON 17-JUN-2024 FROM OTHER HEALTH PROFESSIONAL REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23005929). IT WAS REPORTED THAT RSDL "BOXED HAD A LEAKAGE" (PT: DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PT: PRODUCT COLOUR ISSUE). THE PRODUCT COMPLAINT WAS REPORTED REGARDING THE RDSL 42 ML (MATERIAL F5410ENG). THE CUSTOMER NOTICED THAT ON "OF THE BOXED HAD A LEAKAGE, AS IT LOOKED ON THE OUTSIDE, AND FOUND ONLY ONE WITH A SLIGHT DISCOLORATION OF THE PACKAGE". THE CUSTOMER HAD CONFIRMED AFTER INSPECTING THE BOX AND PACKETS WITHIN, THAT ONLY ONE PACKET APPEARED TO HAVE A SLIGHT DISCOLORATION. THIS COMPLAINT WAS DOCUMENTED UNDER COMPLAINT (B)(4) AND (B)(4) AND AN INVESTIGATION WAS INITIATED. THE OUTCOME OF THE REPORTED EVENTS WAS NOT APPLICABLE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENTS WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: THIS CASE IS REGARDING THE RSDL 42 ML (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME). A CUSTOMER NOTICED THAT RSDL "BOXED HAD A LEAKAGE" (DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PRODUCT COLOUR ISSUE). FURTHER INFORMATION REGARDING THE EVENT WAS LIMITED. THE CAUSALITY OF PRODUCT LEAKAGE AND PRODUCT COLOUR ISSUE 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 AND/OR DEGRADATION OF THE PRODUCT. IN WHICH CASE, USE OF THE LEAKING PACKAGE MAY POTENTIALLY LEAD TO SERIOUS INJURY OR DEATH OF THE USER DUE TO CONTINUED EXPOSURE TO THE OFFENDING CHEMICAL AGENT. THAT BEING SAID, THIS CASE WILL BE CONSIDERED SERIOUS AS PER MEDICAL ASSESSMENT. P.S.: THE CONTACT PHONE NUMBER OF THE REPORTER IS (B)(6) . DUE TO TRANSMISSION ERROR, THE NUMBERS HAVE BEEN ADDED IN THE NARRATIVE AND REMOVED FROM THE GENERAL TAB- REPORTER INFORMATION SECTION.

Description of Event or Problem

BOXED HAD A LEAKAGE [DEVICE LEAKAGE]. IT APPEARED THAT ONLY ONE PACKET HAD A SLIGHT DISCOLORATION [PRODUCT COLOUR ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS CASE REPORT WAS RECEIVED ON 17-JUN-2024 FROM OTHER HEALTH PROFESSIONAL REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23005929). IT WAS REPORTED THAT RSDL "BOXED HAD A LEAKAGE" (PT: DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PT: PRODUCT COLOUR ISSUE). THE PRODUCT COMPLAINT WAS REPORTED REGARDING THE RDSL 42 ML (MATERIAL F5410ENG). THE CUSTOMER NOTICED THAT ON "OF THE BOXED HAD A LEAKAGE, AS IT LOOKED ON THE OUTSIDE, AND FOUND ONLY ONE WITH A SLIGHT DISCOLORATION OF THE PACKAGE". THE CUSTOMER HAD CONFIRMED AFTER INSPECTING THE BOX AND PACKETS WITHIN, THAT ONLY ONE PACKET APPEARED TO HAVE A SLIGHT DISCOLORATION. THIS COMPLAINT WAS DOCUMENTED UNDER (B)(4) AND AN INVESTIGATION WAS INITIATED. THE OUTCOME OF THE REPORTED EVENTS WAS NOT APPLICABLE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENTS WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED ON 08-JUL-2024 FROM OTHER HEALTH PROFESSIONAL IN RESPONSE TO RAISED QUERY. IT WAS CONFIRMED THAT RSDL POUCH WAS NOT USED ON ANYTHING/ANYONE AS REPORTER NOTICED THE LEAKAGE ON THE CARDBOARD PACKAGING MATERIAL. AFTER THAT, REPORTER PUT THE CASE ASIDE. FURTHER, THE REPORTER NOTICED THAT (B)(4) GRAM DIFFERENCE IN THE DAMAGED RSDL POUCH. ON 27SEP2024, THE INVESTIGATION ASSOCIATED WITH THIS PRODUCT QUALITY COMPLAINT WAS COMPLETED AND INCORPORATED INTO THE FINAL COMPLAINT REPORT FOR (B)(4). THE REVIEW NOTED THAT THE RAW MATERIAL AND FINISHED PRODUCT MANUFACTURING PROCESS CONFIRMED THAT THE BATCH MET ALL REQUIRED SPECIFICATIONS, AND NO ISSUES WERE IDENTIFIED DURING OPERATIONS. ALSO, THE VISUAL INSPECTION OF THE RAW MATERIAL PACKET AND RELATED FINISHED PRODUCT BATCHES IN INVENTORY CONFIRMED THAT NO ADDITIONAL LEAKING AND/OR DEFECTIVE PACKETS WERE IDENTIFIED. THE INVESTIGATION DETERMINED THAT A ROOT CAUSE WAS INCONCLUSIVE HOWEVER 3 CONTRIBUTING CAUSES WERE IDENTIFIED: MATERIAL DEFECTIVE/DAMAGED: DURING THE TECHNICAL INSPECTION OF THE RETURNED PACKET, A SMALL AREA OF DELAMINATION WAS FOUND NEAR THE SEAL EDGES THAT APPEARED TO BE A PUNCTURE (VISIBLE FROM BOTH SIDES OF THE PACKET). AN ASSESSMENT CONCLUDED THAT SIGNIFICANT FORCE IS REQUIRED TO PUNCTURE A PACKET AND THAT THE DAMAGE WAS NOT LIKELY CAUSED DURING THE MANUFACTURING PROCESS. METHOD, NO PROCEDURE/PROCESS FOR TASK: CREEP TESTING IS PERFORMED ON THE RAW MATERIAL PACKETS TO ENSURE THAT THE PACKET STRUCTURE REMAINS INTACT WHEN UNDER CONTINUED PRESSURE HOWEVER IT DOES NOT TEST AT VARYING PRESSURES AND/OR TEMPERATURES. ADDITIONALLY, THIS TESTING IS ONLY PERFORMED AS PART OF THE RAW MATERIAL RELEASE TESTING AND IS NOT PERFORMED FOR THE FINISHED PRODUCT PACKETS PRIOR TO RELEASE. METHOD, PROCEDURE/PROCESS INADEQUATE: QUALIFICATION OF THE CURRENT SHIPMENTS VIA AIR AND GROUND HAS NOT BEEN PERFORMED TO EVALUATE THE IMPACT FOR THE CURRENT SHIPPERS, CASE PACKS AND PACKETS ON VARYING TEMPERATURES, DROP TESTING, STACKING AND VIBRATION. THERE IS NO PRODUCT IMPACT. NO PACKETS FROM THIS CASE PACK WERE USED BY THE COMPLAINANT AS THE STAINED BOX AND DEFECTIVE PACKET WERE IDENTIFIED UPON RECEIPT OF THE SHIPMENT AND RETURNED TO THE SITE FOR EVALUATION. THERE HAVE BEEN NO PREVIOUS COMPLAINTS IN THE LAST TWO YEARS FOR LEAKING PACKETS DUE TO A PUNCTURE IN THE PACKET MATERIAL AND NO COMPLAINTS HAVE BEEN RECEIVED FOR ANY OF THE OTHER (B)(4) PACKETS THAT WERE MANUFACTURED FOR THIS BATCH. ADDITIONALLY, A VISUAL INSPECTION OF ALL REMAINING RAW MATERIAL PACKETS AND ASSOCIATED FINISHED PRODUCT BATCHES IN INVENTORY CONFIRMED THAT NO LEAKING PACKETS WERE FOUND. THIS COMPLAINT EVENT HAS NO IMPACT ON THE CONTINUED DISTRIBUTION OF THIS PRODUCT (RSDL BATCH 23005929), OR OTHER PRODUCTS MANUFACTURED WITH THE SAME RAW MATERIAL PACKET (BATCH 0000515349). BASED ON THE INFORMATION IDENTIFIED WITHIN THIS INVESTIGATION, USE OF THE REMAINING PACKETS IN THE FIELD WOULD NOT POSE AN INCREASED RISK TO PATIENT SAFETY AS THE RISK FROM A CHEMICAL WARFARE ATTACK OUTWEIGHS THE RISK OF HAVING OR USING A LEAKING AND/OR DELAMINATED PACKET OF RSDL. COMPANY COMMENT: THIS CASE IS REGARDING THE RSDL 42 ML (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME). A CUSTOMER NOTICED THAT RSDL "BOXED HAD A LEAKAGE" (DEVICE LEAKAGE) AND HAD "SLIGHT DISCOLORATION OF THE PACKAGE" (PRODUCT COLOUR ISSUE). FURTHER INFORMATION REGARDING THE EVENT WAS LIMITED. THE CAUSALITY OF PRODUCT LEAKAGE AND PRODUCT COLOUR ISSUE 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 AND/OR DEGRADATION OF THE PRODUCT. IN WHICH CASE, USE OF THE LEAKING PACKAGE MAY POTENTIALLY LEAD TO SERIOUS INJURY OR DEATH OF THE USER DUE TO CONTINUED EXPOSURE TO THE OFFENDING CHEMICAL AGENT. THAT BEING SAID, THIS CASE WILL BE CONSIDERED SERIOUS AS PER MEDICAL ASSESSMENT.