BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 1230372 · Received November 7, 2008

    Report

    Report Number
    1036844-2008-00232
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 19, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE CATHETER WAS FOUND WITH THE HUB MISSING. ADDITIONAL INFORMATION FROM THE IV MANAGER STATED "IT MUST NOT HAVE BEEN ANYTHING SIGNIFICANT" SINCE SHE HAS NO DETAILS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK