BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECAPPER

    MDR report key: 14415680 · Received May 17, 2022

    Report

    Report Number
    3006655511-2022-00003
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    UDI-DI
    15099590362119
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU5800 CHEMISTRY ANALYZER, THE FSE DETERMINED THAT THE SAFETY SLICE OF THE BLADE WAS DISASSEMBLED BY THE CUSTOMER, AND THE SAFETY COVER OF THE KNIFE HAD NOT BEEN REATTACHED. THE CAUSE OF THE ISSUE IS ATTRIBUTED TO USE ERROR. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCIDENT WITH THE AUTOMATE INSTRUMENT. A LABORATORY TECHNICIAN HAD INJURED HERSELF (CUT HER INDEX FINGER) WHILE CLEANING THE RECAPPER. THE TECHNICIAN'S INDEX FINGER OF HER LEFT HAND HAD BEEN CUT UP TO THE NAIL. THE INJURY WAS TREATED WITH "EMERGENCY MEASURES" IN THE LABORATORY. THE TECHNICIAN WAS TREATED BY THE EMERGENCY SURGERY AND BLOOD WAS DRAWN FOR HEPATITIS/HIV ANALYSIS. THE LAB TECHNICIAN DID NOT RECEIVE ANY MEDICATION AND WAS NOT AT WORK FOR ONE (1) DAY SICK LEAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889494 RECAPPER CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECKMAN COULTER BIOMEDICAL GMBH RECAPPER RETROFIT KIT, MUNSELL (WHITE), FOR UPGRADING WITH R 15099590362119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other