BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN JAR

    MDR report key: 16333785 · Received February 9, 2023

    Report

    Report Number
    16333785
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 30, 2023
    Manufacturer
    E K INDUSTRIES, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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). MANUFACTURER RESPONSE FOR FORMALIN JAR, FORMALIN JAR (PER SITE REPORTER) REQUESTED MANUFACTURER ITEM# FROM SITE, ASKED [REDACTED NAME] TO RETRIEVE, PULLED TRACKER REPORT FOR FORMALIN JARS. CC'D [REDACTED NAME] AND ASKED IF HE WOULD BE THE VAN TO EVALUATE NEW PRODUCTS DUE TO ALL OF THE ISSUES WITH THESE (BUGS IN JARS, CRACKED LIDS, QUALITY ISSUES). [REDACTED DATE]- SAMPLE RETRIEVED. [REDACTED DATE]- EMAILED [REDACTED NAME], MEDLINE. [REDACTED DATE]- EMAIL SENT TO EKI REP.; EKI REP RESPONSE RECEIVED AND WILL TAKE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816290 FORMALIN JAR FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. EKI4499100X60 2215441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown