BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR

    MDR report key: 21032763 · Received December 29, 2024

    Report

    Report Number
    3006260740-2024-07832
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    September 2, 2014
    Report Date
    December 3, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT 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: CLAUDE JEFFREY RENAUD, YING YING SEOW, AND HUI SIONG TEH (2014). TRANSJUGULAR TUNNELLED DIALYSIS CATHETER TIP PLACEMENT INTO THE INFERIOR VENA CAVA UPPER SEGMENT AFTER LENGTH OVERESTIMATION. JOURNAL OF VASCULAR ACCESS, 16(1): 72-75. DOI: 10.5301/JVA.5000295. 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 IN AN ARTICLE IN THE "JOURNAL OF VASCULAR ACCESS" TITLED "TRANSJUGULAR TUNNELED DIALYSIS CATHETER TIP PLACEMENT INTO THE INFERIOR VENA CAVA UPPER SEGMENT AFTER LENGTH OVERESTIMATION" THAT SOMETIME POST A TUNNELED DIALYSIS CATHETER PLACEMENT VIA THE LEFT INTERNAL JUGULAR VEIN, THE CATHETER ALLEGEDLY HAD A POOR FLOW. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436608 HEMOSTAR DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male