BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWREN'S VERONAL BUFFER

    MDR report key: 12468897 · Received September 14, 2021

    Report

    Report Number
    9610806-2021-00062
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 14, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    KQJ
    UDI-DI
    00842768003981
    PMA / PMN Number
    K050928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE GLASS OF THE BOTTLE WAS BROKEN STRUCTURALLY, CAUSED BY A MAJOR IMPACT. THE LABEL WAS APPLIED CORRECTLY, AND THE GLASS PIECES WERE ATTACHED TO THE LABEL AS WELL, INDICATING THAT THE VIAL WAS NOT DAMAGED DURING LABELING. THERE IS NO INDICATION OF A SYSTEMATIC FAILURE OF PROCESSES OR ANY MATERIAL ISSUES. THE MOST LIKELY CAUSE OF THE EVENT WAS A SHIPPING AND HANDLING ISSUE. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    WHILE OPENING A BOTTLE OF OWREN'S VERONAL BUFFER (OVB), THE CUSTOMER RECEIVED A CUT ON THEIR FINGER AFTER THE BOTTLE SHATTERED IN THEIR HAND. THE CUSTOMER CLEANED THE WOUND AND DID NOT SEEK MEDICAL ATTENTION. THE BOX FROM WHICH THE BROKEN BOTTLE WAS TAKEN HAD WET MARKS ON IT AND LOOKED PHYSICALLY DAMAGED. THE CUSTOMER DISCARDED THE REMAINING BOTTLES OF OVB IN THE BOX. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369227 OWREN'S VERONAL BUFFER OWREN'S VERONAL BUFFER KQJ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH OWREN'S VERONAL BUFFER 554689 00842768003981

    Patients

    Seq Age Sex Outcome Treatment
    1