BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOT,4FR POWERMIDLINE

    MDR report key: 7287176 · Received February 21, 2018

    Report

    Report Number
    3006260740-2018-00243
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 21, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    PND
    UDI-DI
    00801741108761
    PMA / PMN Number
    K153393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REBU2259 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON MONDAY (B)(6) A POWER MIDLINE DEVELOPED A LEAK. IT WAS STATED THE MIDLINE WAS REMOVED AND DISPOSED OF BY THE BEDSIDE NURSE AND A QRR WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131194 DOT,4FR POWERMIDLINE MIDLINE CATHETER PND BARD ACCESS SYSTEMS P4154108D REBU2259 00801741108761

    Patients

    Seq Age Sex Outcome Treatment
    1