BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3FR SL PROVENA MIDLINE MAX BARRIER KIT

    MDR report key: 9597549 · Received January 16, 2020

    Report

    Report Number
    3006260740-2020-00152
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    PND
    UDI-DI
    00801741153952
    PMA / PMN Number
    K153393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDR1870 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED CUSTOMER REPORTS A HOLE LOCATED IN THE PURPLE LUMEN COMING OFF THE MIDLINE (EXTENSION). NO OTHER INFORMATION WAS PROVIDED. ON 1/15/2020: NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58405 3FR SL PROVENA MIDLINE MAX BARRIER KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS PND BARD ACCESS SYSTEMS N/A REDR1870 00801741153952

    Patients

    Seq Age Sex Outcome Treatment
    1