BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT

    MDR report key: 3063700 · Received April 12, 2013

    Report

    Report Number
    3006425876-2013-00050
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K002507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED INTO THE PT IN THE INTENSIVE CARE UNIT. THE CLINICIAN ADMINISTERED MEDICATION THROUGH THE 3-WAY STOPCOCK. TWO OF THE 3-WAYS ARE BROKEN ON THE STOPCOCK. BECAUSE OF THE DAMAGE, THE PT DIDN'T RECEIVE THE MEDIATION PROPERLY. THE PT HAD PROBLEMS WITH BLOOD PRESSURE BECAUSE MEDICATION FAILED. AS A RESULT, THEY REMOVED AND REPLACED THE 3-WAY STOPCOCK. THERE WAS A DELAY IN TREATMENT AND NO PT DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158131 MULTI-LUMEN/PSI KIT MULTI-LUMEN ACCESS CATHETERS DYB ARROW INTERNATIONAL, INC. ZF3015229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK