BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16477815 · Received March 3, 2023

    Report

    Report Number
    16477815
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    E K INDUSTRIES, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731975 PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ) FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 4499-100, 24499-100, 24499-100 2215441, 2210801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown