BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIROS CLOSED MALE LUER

    MDR report key: 5575992 · Received April 11, 2016

    Report

    Report Number
    MW5061673
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    March 29, 2016
    Report Date
    April 11, 2016
    Manufacturer
    ICU
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    SPIRO CAME OFF TUBING WHILE PREPARING CHEMOTHERAPY TUBING - SPINNING SPIROS CLOSED MALE LUER, RED CAP REF (B)(4), LOT 3130840, EXP DATE 2020-10. CHEMO CLAVE IS SIMILAR TO THE SPIROS CLOSED MALE LUER RED CAP WITH VARIATION BETWEEN GROVES BUT COULD POSSIBLE TO INTERCHANGE CHEMO SPIROS WITH REGULAR SPIROS CLOSED MALE LUER W/RED CAP AND SPIROS CLOSED MALE LUER RED CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223457 SPIROS CLOSED MALE LUER SPIROS CLOSED MALE LUER FPA ICU CH2000S-C 3130840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention