BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 21026499 · Received December 27, 2024

    Report

    Report Number
    3003674698-2024-00843
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    October 18, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDSOURCE LABS, LLC
    Product Code
    FOZ
    UDI-DI
    00810094574178
    PMA / PMN Number
    K223788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A FOLLOW-UP MDR REPORT WILL BE FILED ONCE WE HAVE RECEIVED THE RESULTS OF THE INVESTIGATION THAT IS BEING PERFORMED ON THE RETENTION SAMPLES FOR THAT PART AND LOT NUMBER.

    Description of Event or Problem · 0

    MEDSOURCE RECEIVED FEEDBACK FROM OUR CUSTOMER STATING THAT: PROVIDER HAD INSERTED THE NEEDLE/CATHLON IN VEIN, FLASH DETECTED, STARTED ADVANCING CATHETER AND REMOVING NEEDLE. AFTER NEEDLE WAS REMOVED, CATHETER COULD NOT BE ADVANCED FURTHER TO PROPERLY PLACE CATHLON. WHEN PROVIDER WENT TO REMOVE CATHLON, IT TUGGED AT THE SKIN AND FINALLY CAME OUT WITH THE END LOOKING BUSTED OPEN. ADDITIONALLY, THEY STATED THAT THEY WERE NOT ABLE TO GET FLUIDS TO FLOW THROUGH THE PRODUCT. DUE TO THE POSSIBILITY OF CATHETER FRAGMENTS REMAINING IN THE VEIN FROM THE APPEARANCE THEY DESCRIBED IN THE COMPLAINT, IT WAS DETERMINED THAT THIS WAS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513317 CURAPLEX CURAPLEX CURASLIDE BLOOD CONTROL 20G X 1IN FOZ MEDSOURCE LABS, LLC 1613-862202 30862/0537 00810094574178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown