BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE CONNECTOR 12009

    MDR report key: 5396793 · Received January 21, 2016

    Report

    Report Number
    MW5059725
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 12, 2016
    Manufacturer
    ICU MEDICAL/HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FEMALE-FEMALE LUER ADAPTERS, MFG BY ICU MEDICAL AND SOLD BY HOSPIRA HAVE TRANSLUCENT PARTICLES IN THE PACKAGING AND ON THE STERILE DEVICES. THESE APPEAR TO BE PLASTIC BITS LEFT OVER FROM THE MFG PROCESS. THESE BITS OF PLASTIC ARE CONCERNING AS THEY COULD RESULT IN EMBOLISM OR OTHER FOREIGN BODY EVENTS. THIS IS THE 2ND LOT WITH WHICH THIS HAS OCCURRED. HOSPIRA WAS NOTIFIED, BUT NO ONE FROM HOSPIRA HAS CONTACTED US FOR MORE INFO AND TO REQUEST THAT WE SEND THE PRODUCT FOR EVAL. ICU MEDICAL, INC. DOUBLE CONNECTOR 12009 LOT 57-719-SL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41444 DOUBLE CONNECTOR 12009 DOUBLE CONNECTOR 12009 FPA ICU MEDICAL/HOSPIRA 12009 57-719-SL

    Patients

    Seq Age Sex Outcome Treatment
    1