BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A

    MDR report key: 21590182 · Received March 12, 2025

    Report

    Report Number
    3006260740-2025-01445
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 3, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    UDI-DI
    00801741137952
    PMA / PMN Number
    K162894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 THAT THE NEEDLE WOULD NOT RETRACT. PLACER SAID GUIDEWIRE WENT SMOOTH, THEN THREADED CATHETER WITH LITTLE RESISTANT THEN TRIED TO SAFETY THE NEEDLE AND WOULD NOT REACT. PLACER HAD TO PULL NEEDLE BACK THEN IT RETRACTED AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917012 MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A MIDLINE CATHETER FOZ C.R. BARD, INC. (BASD) -3006260740 N/A REJW0676 00801741137952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other