BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC

    MDR report key: 24498056 · Received March 3, 2026

    Report

    Report Number
    3006260740-2026-01347
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 17, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741048333
    PMA / PMN Number
    K060812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 ON (B)(6) 2026, A SINGLE-USE IMPLANTABLE DRUG DELIVERY DEVICE (IDD) WAS PLACED. ON THE MORNING OF (B)(6) 2026, THE CHARGE NURSE ADMINISTERED INTRAVENOUS FLUIDS TO THE PATIENT. WHILE PRIMING THE CHEST WALL PORT VIA THE IDD, LEAKAGE WAS DETECTED AT THE CONNECTION POINT BETWEEN THE NEEDLE-FREE INFUSION CONNECTOR AND THE IDD EXTENSION TUBE. INSPECTION REVEALED A CRACK AT THE TIP OF THE IDD EXTENSION TUBE. A NEW SINGLE-USE IMPLANTABLE DRUG DELIVERY DEVICE CATHETER WAS IMMEDIATELY REPLACED. NO HARM WAS CAUSED TO THE PATIENT DUE TO THE TIMELY DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560756 POWERLOC PORT ACCESS NEEDLE FPA C.R. BARD, INC. (BASD) -3006260740 N/A ASKNFS005 00801741048333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other