BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL

    MDR report key: 3150556 · Received June 4, 2013

    Report

    Report Number
    1036844-2013-00188
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K940079
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED VIA MAUDE EVENT REPORT. THE PT HAD 2 CAROTID ENDARTERECTOMY SO, THEY DID NOT WANT TO USE THE JUGULAR FOR LINE PLACEMENT. THE SUBCLAVIAN VESSEL WAS BEING USED TO INSERT THE LINE WHEN THE INCIDENT OCCURRED. IT WAS NOTED THEY WERE USING AN ARROWGARD BLUE PSI KIT. THE RISK MANAGER HAS THE ONE PIECE AND THE SECOND PIECE REMOVED FROM THE PT IS IN PATHOLOGY, SHE WILL TRY TO OBTAIN AND SEND BOTH SEGMENTS BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246253 PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention