SPECIFIC/TOTAL IGE EIA

Additional Manufacturer Narrative

THE DISTRIBUTOR PROVIDED PHOTOGRAPHIC EVIDENCE THAT THE OUTER CARTON WAS STAINED, AND PHOTOS OF CONTAINER OF STOP SOLUTION APPEARED TO BE FILLED TO NORMAL LEVELS. PRODUCT IS FILLED TO 300 ML IN A 500 ML BOTTLE. AN MDR WAS NOT FILED BASED ON THE PHOTOGRAPHIC EVIDENCE THAT APPEARED TO SHOW A NORMALLY FILLED BOTTLE OF STOP SOLUTION. THE PRODUCT WAS RETURNED TO HYCOR AFTER SIGNIFICANT DELAYS IN CUSTOMS. THE RETURNED PRODUCT WAS WEIGHED AND COMPARED TO WEIGHT OF PRODUCT IN INVENTORY TO DETERMINE IF HAD LEAKED APPROXIMATELY 30 ML OF FLUID. ADDITIONALLY, WHEN PRESSURE IS APPLIED TO THE PLASTIC BOTTLE, LEAKING WAS EVIDENT AT THE CONTAINER CAP. 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) # (B)(4), AS AN ABUNDANCE OF CAUTION, HYCOR HAS OPTED TO FILE AN MDR - INTERNAL REFERENCE: (B)(4). THE INITIAL DECISION TO NOT FILE AN MDR WAS BASED ON PHOTOGRAPHIC EVIDENCE THAT APPEARED TO DEMONSTRATE THAT THE STOP SOLUTION HAD NOT LEAKED. INSPECTION OF THE RETURNED PRODUCT DID DEMONSTRATE THAT A SMALL AMOUNT OF STOP SOLUTION (1N SODIUM HYDROXIDE) DID LEAK. ROOT CAUSE OF THE LEAK IN STILL UNDER INVESTIGATION. (B)(4).

Description of Event or Problem

THE DISTRIBUTOR REPORTED THE SHIPMENT CONTAINING STOP SOLUTION (1N SODIUM HYDROXIDE) WAS RECEIVED WITH A STAINED CARTON, SUGGESTING LEAKAGE OF AN ITEM IN THE PACKAGE. PHOTOGRAPHIC EVIDENCE PROVIDED BY THE DISTRIBUTOR SHOWED A STAINED CARTON, BUT PHOTOGRAPHS OF THE BOTTLE OF STOP SOLUTION DID NOT APPEAR TO SHOW THAT THE BOTTLE HAD LEAKED. (THE CONTAINER IS FILLED TO 300 ML IN A 500 ML BOTTLE). HYCOR REQUESTED PRODUCT BE RETURNED TO HYCOR. PRODUCT WAS SHIPPED BY DISTRIBUTOR ON 03/16/2018 AND WAS HELD BY CUSTOMS DELAYS UNTIL IT WAS RELEASED BY CUSTOMS ON 04/06/2018. THE PRODUCT WAS RECEIVED BY HYCOR ON 04/09/2018, INSPECTION OF PRODUCT DEMONSTRATED THAT THERE WAS LEAK OF STOP SOLUTION AS DETERMINED BY COMPARING THE MASS OF THE CONTAINER TO THE MASS OF CONTAINERS IN INVENTORY. THERE WAS A MINOR LEAK OF APPROXIMATELY 30 ML OF STOP SOLUTION. THERE WERE NO ADVERSE OUTCOMES REPORTED TO HYCOR. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, WE ARE FILING AN MDR.