PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ)

Description of Event or Problem

THERE ARE 8 EVENTS TO REPORT IN THIS REPORT REGARDING EKI INDUSTRIES FORMALIN CONTAINERS. EVENT 1: [DATE REDACTED]: WHEN STOCKING PROCEDURE ROOM WITH FORMALIN JARS NOTED THAT IN EXCESS OF 30 FORMALIN JARS HAD SEVERELY CRACKED LIDS. ALL REMOVED FROM ROOMS. EVENT 2: [DATE REDACTED]: OPENED UNUSED 60ML FORMALIN BOX AND NOTICED TWO CRACK BOTTLES, ONE HALFWAY OPEN AND THE OTHER CRACKED AROUND THE SEAL. LOT# 2215441, EXP: [DATE REDACTED]. EVENT 3: [DATE REDACTED]: TWO FORMALIN JARS WERE BROKEN. NO SPECIMEN WAS IN JAR. THE COVER PULLS APART IN MY HAND. EVENT 4: [DATE REDACTED]: DURING PROCEDURE IN ADVANCED ENDOSCOPY SEVERAL FORMALIN CONTAINERS NOTED TO HAVE CRACKED LIDS. EVENT 5: [DATE REDACTED]: ONE FORMALIN VIAL CAP WAS CRACKED PRIOR TO USE. ONE VIAL WAS CRACKED SECURING IT TO VIAL. LOT# 2215441, [DATE REDACTED]. EVENT 6: [DATE REDACTED]: FORMALIN VIAL TOP CRACKED WITH IT WAS BEING SECURED. NO DAMAGE TO SPECIMEN. NEW TOP PLACED ON VIAL. EVENT 7: [DATE REDACTED]: TAKING FORMALIN OUT OF THE NEW BOX, LID ON CROOKED AND NEVER OPENED, BRAND NEW, JAR EMPTY. EVENT 8: [DATE REDACTED]: [REDACTED NAME] ALSO REPORTING CONTACT. LID CRACKING WITH MINIMAL TWISTING. WE HAVE HAD ANOTHER INCIDENCE TODAY WITH SAME LOT NUMBER. WE ORDER THEM THROUGH OUR MEDLINE DISTRIBUTOR. COMPANY NAME ON BOTTLE; EKI (1-800-283-4244). EVENT 9: [DATE REDACTED]: A NEW BOX OF UNOPENED FORMALIN CONTAINERS WAS OPENED, AND A FORMALIN CONTAINER WAS FOUND TO HAVE A BLUE "THING" FLOATING IN IT. EVENTS 10: FORMALIN JAR (40ML) WAS REMOVED FROM SUPPLY ROOM. EKI 10% FORMALIN FIXATIVE NOTED A SMALL BROWN PARTICLE FLOATING IN CLOSED FORMALIN JAR. JAR WAS IN SUPPLY ROOM. MANUFACTURE LETTER OF INVESTIGATION ATTACHED TO THIS REPORT. ITEM NUMBER 4499100X60ML IN EVENTS 1, 2, 7, 8, 9, LOT# 2215441, EXP: [DATE REDACTED] FOR ONE EVENT. ITEM NUMBER 24499-100X20ML IN EVENTS 3, 4, 5, 6, LOT# 2215441, EXP [DATE REDACTED] FOR ONE EVENT. ITEM NUMBER 24499-100X120ML IN EVENT 10, LOT #2210801, EXP: [DATE REDACTED]. MANUFACTURER RESPONSE FOR FORMALIN CONTAINERS, PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.) SCREW CAP WARNING LABEL / PATIENT INFORMATION NONSTERILE (PER SITE REPORTER). THEY HAVE INVESTIGATED SOME REPORTS, ONE OF WHICH THERE IS AN OUTCOME FOR AND THE LETTER IS ATTACHED, CONFIRMING THE PRESENCE OF A BUG IN THE CONTAINER.