BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F

    MDR report key: 17485496 · Received August 9, 2023

    Report

    Report Number
    3006260740-2023-03401
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 17, 2023
    Report Date
    October 16, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741036583
    PMA / PMN Number
    K050185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE 5FR POWERLINE S/L CATHETER WAS RETURNED FOR EVALUATION. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL EVALUATIONS WERE PERFORMED. THE TISSUE CUFF WAS LOOSE AND HAD RESIDUE AND NOTED TO MOVE FREELY THROUGHOUT THE CATHETER. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO BOND ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: D4 (EXPIRATION DATE: 06/2027), G3 . 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.

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 06/2027). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE CUFF ALLEGEDLY GOT LOOSE ON THE TUNNELED CENTRAL LINE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF ALLEGEDLY GOT LOOSE ON THE TUNNELED CENTRAL LINE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904312 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 REHN2962 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown