Description of Event or Problem · 1
ON (B)(6) 2014, A CUSTOMER CALLED BIO-RAD LABORATORIES TECH SUPPORT DEPARTMENT AND REPORTED THAT SHE SPLASHED A DROP OF LIQUID INTO HER EYE AFTER WASHING HER PLATE WITH THE PW41 WASHER WHEN RUNNING THE GS HBSAG EIA 3.0 ASSAY. THIS HAPPENED WHEN SHE WAS TAPPING THE PLATE TO REMOVE THE EXCESS WASH. THE CUSTOMER VERIFIED SHE WAS NOT USING PERSONAL PROTECTIVE EQUIPMENT FOR EYE/FACE PROTECTION. BY NOT WEARING THE APPROPRIATE EYE/FACE PROTECTION, THE CUSTOMER MAY HAVE BEEN EXPOSED TO POTENTIALLY INFECTIOSUS HUMAN SERUM AND/OR PLASMA. THE GS HBSAG EIA 3.0 ASSAY PACKAGE INSERT ON PAGE 6-7 MENTIONS "2. WEAR PROTECTIVE CLOTHING, INCLUDING LAB COAT, EYE/FACE PROTECTION AND DISPOSABLE GLOVES ARE RECOMMENDED WHILE HANDLING KIT REAGENTS. 5. THE TEST KIT SHOULD BE HANDLED BY QUALIFIED PERSONNEL TRAINED IN LABORATORY PROCEDURES AND FAMILIAR WITH THEIR POTENTIAL HAZARDS. WEAR APPROPRIATE PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION AND HANDLE APPROPRIATELY WITH THE REQUISITE GOOD LABORATORY PRACTICES." BIO-RAD TSR ADVISED THE CUSTOMER TO FOLLOW HER LAB "NEEDLESTICK PROTOCOL" SINCE AN EYE SPLASH IS CONSIDERED THE SAME. THE CUSTOMER VERIFIED THAT SHE FOLLOWED UP WITH MEDICAL CONSULTATION PER HER LAB'S PROTOCOL. THE CUSTOMER STATED THAT WHEN THE PW41 WAS WASHING IT APPEARED THAT THE PLATE HAD OVERFLOWED AND THE LIQUID WAS ON THE BOTTOM OF THE PLATE AND SPLASHED BACK AT HER. SUBSEQUENTLY CUSTOMER CONFIRMED THAT THERE WAS NO RECORD OF MAINTENANCE BEING PERFORMED AND THAT THEY DID NOT HAVE A MAINTENANCE KIT. THE PW41 MATRM ON PAGES 14-21 TO 14-25 MENTIONS REQUIRING SEMI-ANNUAL MAINTENANCE OF THE WASHER. HOWEVER, CUSTOMER WAS UNABLE TO REPLICATE WASHER OVERFLOW ON SUBSEQUENT RUNS AND THE WASHER WAS CONFIRMED TO BE ASPIRATING AND DISPENSING CORRECTLY. BIO-RAD TSR PROVIDED CUSTOMER WITH A MAINTENANCE KIT AT NO CHARGE.