BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER STABILIZATION, PICC/CENTRAL LINE

    MDR report key: 21938705 · Received April 30, 2025

    Report

    Report Number
    3006260740-2025-02714
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 21, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    KMK
    UDI-DI
    00801741083488
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD 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 BD. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER "BY REMOVING THE STAT LOCK IT IS OPEN, AND THE PLURAL DRAIN IS FREE. WE CHANGE THE STAT LOCK, CLOSE IT AND BEFORE CLOSING THE DRESSING, ABOUT 1 MINUTE AFTER CLOSING THE SYSTEM THE STAT LOCK OPENS UNDER THE EYES OF THE NURSE WHO NOTIFIES THE HEMATOLOGIST AND THE PULMONOLOGIST. ON THE RADIO ID WE SEE THAT THE STAT LOCK HAS BEEN OPEN SINCE THE BEGINNING AND THAT THE DRAIN IS USED EVERY DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181430 CATHETER STABILIZATION, PICC/CENTRAL LINE CATHETER SECUREMENT DEVICE KMK C.R. BARD, INC. (BASD) -3006260740 N/A JUJS0142 00801741083488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other