BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 338395 · Received June 13, 2001

    Report

    Report Number
    MW1022191
    Event Type
    Malfunction
    Date Received
    June 13, 2001
    Date of Event
    June 8, 2001
    Report Date
    June 8, 2001
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC. CUSTOM TRAY DIV.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    VAD ACCESS KITS MFG BY CHURCHILL MEDICAL SYSTEMS, INC CONTAINED 10 U/ML CONCENTRATION HEPARIN FLUSHES RATHER THAN 100 U/ML CONCENTRATION AS LABELED. THE LOT # FOR THE PORT ACCESS KITS CONTAINING WRONG HEPARIN CONCENTRATION IS 1828. LOT # AND EXP OF 10 U/ML HEPARIN FLUSHES ARE LOT # 010052 AND 010048 WITH EXP 7/02 MFG BY ELKIN SINN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26944 * VAD ACCESS TRAY FMI CHURCHILL MEDICAL SYSTEMS, INC. CUSTOM TRAY DIV. * 1B28

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other 10 ML MULTI DOSE VIAL LOT 010052| 2) 010048 ELKINS SINN| 1) HEPARIN (HEP-LOCK) 10 UNITS/ML