BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F

    MDR report key: 18361665 · Received December 20, 2023

    Report

    Report Number
    3006260740-2023-05768
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 7, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741036590
    PMA / PMN Number
    K051417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: D4 (EXPIRATION DATE: 03/2027) . H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, DURING THE ROUTINE NEEDLE-FREE CONNECTORS CHANGE, CLAMPS WERE NEEDED TO BE PLACED DIRECTLY ON THE COLORED PLASTIC PARTS OF THE CATHETER TO REMOVE THE CONNECTORS, WHICH ALLEGEDLY RESULTED IN A STRIPPING DAMAGE TO THE COLORED PLASTIC PIECES. IT WAS FURTHER REPORTED THAT NEEDLE-FREE CONNECTORS WOULD NOT LOOSEN WITHOUT A CLAMP ON THE NEEDLE-FREE CONNECTORS AND ON THE COLORED PLASTIC PIECE OF THE CATHETER AND TURNING THE CLAMPS IN OPPOSITE DIRECTIONS. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106236 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 REHN3046 00801741036590

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female