SPECIFIC/TOTAL IGE EIA

Additional Manufacturer Narrative

THE DISTRIBUTOR DID NOT OPEN THE BOXES TO DETERMINE WHAT IF ANYTHING WAS LEAKING OR IF THE APPARENT DAMAGE TO THE OUTER CARTON WAS CAUSED BY AN OUTSIDE SOURCE. PRODUCT WAS SHIPPED "AS IS" TO THEIR CUSTOMER. HYCOR ATTEMPTED TO INVESTIGATE THE REPORTED ISSUE FURTHER BY REQUESTING ADDITIONAL DETAILS, BUT NONE WERE PROVIDED, EXCEPT IMAGES OF THE DAMAGED BOXES EXHIBITING WATER MARKS AND DAMAGED TO SHIPPING CARTONS. OUR FOLLOW-UP EFFORTS HAVE BEEN EXHAUSTED AS WE WERE UNABLE TO DETERMINE WHETHER THE STOP SOLUTION WAS THE LIQUID FOUND BY THE DISTRIBUTOR. FURTHERMORE, THERE WERE NO REPORTED ADVERSE OUTCOMES TO HYCOR. HOWEVER, GIVEN THAT THE 1N SODIUM HYDROXIDE SOLUTION CAN CAUSE CAUSTIC BURNS TO THE SKIN, EYES, AND RESPIRATORY SYSTEM PER SAFETY DATA SHEET (SDS) #601A.07, AS AN ABUNDANCE OF CAUTION, HYCOR HAS OPTED TO FILE AN MDR · INTERNAL REFERENCE: (B)(4). THE REASON THIS MDR IS FILED SO LATE IS BECAUSE HYCOR WENT THROUGH AN ORGANIZATIONAL CHANGE IN JANUARY 2017 AND THE PERSON WHO ORIGINALLY SET UP HYCOR'S EMDR CERTIFICATES REGISTERED UNDER HIS OWN NAME AND NOT A GENERAL HYCOR ACCOUNT. WE HAD TO RE-ASSIGN THE CERTIFICATE TO HYCOR AND GO THROUGH THE GATEWAY VALIDATION PROCESS AND WE RAN INTO TECHNICAL ISSUES WITH THE VALIDATION PROCESS. THEN FDA UPDATED THE EMDR SOFTWARE THAT CAUSED US TO HAVE TO START THE VALIDATION PROCESS OVER. WE HAD SEVERAL INTERACTIONS WITH THE EMDR HELP DESK AND WE WERE FINALLY ABLE TO COMPLETE THE WHOLE EMDR GATEWAY VALIDATION PROCESS THIS PAST WEEK AND CAN NOW FILE EMDRS. WE SPOKE WITH (B)(4) ON MARCH 31, 2017 AND HE INSTRUCTED US TO ADD OUR LATE EXPLANATION HERE. WE OFFERED TO FILE A PAPER COPY ON MARCH 31ST BUT (B)(4) STATED THAT THE ONLY OPTION WAS TO FILE EMDRS NOW.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THE SHIPMENT CONTAINING STOP SOLUTION (1N SODIUM HYDROXIDE) WAS RECEIVED DAMAGED AS THE PALLET CONTAINING THE SHIPPING CARTONS WITH PRODUCT WAS WET. WE WERE NOT ABLE TO DETERMINE IF THERE WAS AN ACTUAL LEAK OF STOP SOLUTION OR IF THE SHIPPING CARTONS HAD GOTTEN WET BY ANOTHER MEANS (E.G. CONDENSATION, WATER SPILL, ETC.) THERE WERE NO ADVERSE OUTCOMES REPORTED TO HYCOR. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, WE ARE FILING AN MDR.