BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F

    MDR report key: 18612950 · Received January 31, 2024

    Report

    Report Number
    3006260740-2024-00254
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    October 18, 2023
    Report Date
    January 10, 2024
    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
    TX, 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 RECORDS WILL BE 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 (EXPIRY 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 SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DID NOT UNCOIL. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD INFUSION PROBLEM.THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421220 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 REHV1064 00801741036590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown